Explants |
1 |
1 |
2.04% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 3.45% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Infections |
5 |
4 |
8.16% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 5 | 4 | 13.79% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Hemorrhages |
2 |
2 |
4.08% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 3.45% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 6.25% | 0 | 0 | 0.00% |
Programming Related |
129 |
38 |
77.55% |
0 | 0 | 0.00% | 11 | 3 | 42.86% | 0 | 0 | 0.00% | 52 | 19 | 65.52% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 66 | 16 | 100.00% | 0 | 0 | 0.00% |
Other Adverse Events |
150 |
48 |
97.96% |
0 | 0 | 0.00% | 22 | 7 | 100.00% | 0 | 0 | 0.00% | 72 | 28 | 96.55% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 66 | 16 | 100.00% | 0 | 0 | 0.00% |
Click to Show Other Adverse Events Details
|
|
Anxiety |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 18.75% | 0 | 0 | 0.00% |
Bradykinesia |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 5 | 2 | 12.50% | 0 | 0 | 0.00% |
Depression |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 6.90% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Dysarthria |
0 | 0 | 0.00% | 3 | 2 | 28.57% | 0 | 0 | 0.00% | 6 | 5 | 17.24% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 9 | 4 | 25.00% | 0 | 0 | 0.00% |
Dyskinesias |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 12.50% | 0 | 0 | 0.00% |
Dystonia |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 2 | 12.50% | 0 | 0 | 0.00% |
Exacerbation of Tics |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 18.75% | 0 | 0 | 0.00% |
Gait Disorder |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 6.90% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Lethargy |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 4 | 4 | 13.79% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 1 | 6.25% | 0 | 0 | 0.00% |
Nausea or Vertigo |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 7 | 7 | 24.14% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Obsessive-Compulsive Behaviors (new or exacerbated) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 12.50% | 0 | 0 | 0.00% |
Other |
0 | 0 | 0.00% | 4 | 2 | 28.57% | 0 | 0 | 0.00% | 29 | 18 | 62.07% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 32 | 9 | 56.25% | 0 | 0 | 0.00% |
Paresthesias |
0 | 0 | 0.00% | 3 | 3 | 42.86% | 0 | 0 | 0.00% | 10 | 8 | 27.59% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 12.50% | 0 | 0 | 0.00% |
Pulse Generator Removal |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 1 | 3.45% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Weight Gain (>10 pounds) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 10.34% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Click to Hide Other Adverse Events Details
|
Other Adverse Events Details do not include the single instance events
|
|
All Targets |
n ( # ) |
Number of adverse events by category (where # is total number of adverse events). |
subjects ( # ) |
Number of subjects with an adverse event by category (where # is total number of subjects with leads). |
% {Total Cohort} |
Total number of leads with an adverse event out of total subjects. |
|
Individual Target |
n ( # ) |
Number of adverse events by category for the target (where # is total number of adverse events for the target). |
subjects ( # ) |
Number of participants with an adverse event and the target by category (where # is total number of participants with the target). |
% |
Percent of total number of participants with the target by category. |
|
Explants |
6 |
5 |
9.43% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 6 | 5 | 15.62% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Infections |
7 |
6 |
11.32% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 7 | 6 | 18.75% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Hemorrhages |
2 |
2 |
3.77% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 3.12% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 5.88% | 0 | 0 | 0.00% |
Programming Related |
152 |
42 |
79.25% |
0 | 0 | 0.00% | 14 | 3 | 42.86% | 0 | 0 | 0.00% | 61 | 22 | 68.75% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 77 | 17 | 100.00% | 0 | 0 | 0.00% |
Other Adverse Events |
169 |
51 |
96.23% |
0 | 0 | 0.00% | 25 | 7 | 100.00% | 0 | 0 | 0.00% | 76 | 30 | 93.75% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 78 | 17 | 100.00% | 0 | 0 | 0.00% |
Click to Show Other Adverse Events Details
|
|
Anxiety |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 17.65% | 0 | 0 | 0.00% |
Bradykinesia |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 7 | 2 | 11.76% | 0 | 0 | 0.00% |
Depression |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 9.38% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Dysarthria |
0 | 0 | 0.00% | 3 | 2 | 28.57% | 0 | 0 | 0.00% | 6 | 5 | 15.62% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 12 | 5 | 29.41% | 0 | 0 | 0.00% |
Dyskinesias |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.76% | 0 | 0 | 0.00% |
Dystonia |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 2 | 11.76% | 0 | 0 | 0.00% |
Exacerbation of Tics |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 17.65% | 0 | 0 | 0.00% |
Gait Disorder |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 6.25% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Lethargy |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 4 | 4 | 12.50% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 1 | 5.88% | 0 | 0 | 0.00% |
Nausea or Vertigo |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 7 | 7 | 21.88% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Obsessive-Compulsive Behaviors (new or exacerbated) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.76% | 0 | 0 | 0.00% |
Other |
0 | 0 | 0.00% | 6 | 2 | 28.57% | 0 | 0 | 0.00% | 31 | 19 | 59.38% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 39 | 11 | 64.71% | 0 | 0 | 0.00% |
Paresthesias |
0 | 0 | 0.00% | 3 | 3 | 42.86% | 0 | 0 | 0.00% | 10 | 8 | 25.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.76% | 0 | 0 | 0.00% |
Pulse Generator Removal |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 2 | 6.25% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Weight Gain (>10 pounds) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 9.38% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Click to Hide Other Adverse Events Details
|
Other Adverse Events Details do not include the single instance events
|
|
All Targets |
n ( # ) |
Number of adverse events by category (where # is total number of adverse events). |
subjects ( # ) |
Number of subjects with an adverse event by category (where # is total number of subjects with leads). |
% {Total Cohort} |
Total number of leads with an adverse event out of total subjects. |
|
Individual Target |
n ( # ) |
Number of adverse events by category for the target (where # is total number of adverse events for the target). |
subjects ( # ) |
Number of participants with an adverse event and the target by category (where # is total number of participants with the target). |
% |
Percent of total number of participants with the target by category. |
|
Explants |
7 |
6 |
11.11% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 6 | 5 | 15.62% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 5.56% | 0 | 0 | 0.00% |
Infections |
7 |
6 |
11.11% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 7 | 6 | 18.75% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Hemorrhages |
2 |
2 |
3.70% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 3.12% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 5.56% | 0 | 0 | 0.00% |
Programming Related |
165 |
43 |
79.63% |
0 | 0 | 0.00% | 17 | 3 | 42.86% | 0 | 0 | 0.00% | 61 | 22 | 68.75% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 87 | 18 | 100.00% | 0 | 0 | 0.00% |
Other Adverse Events |
181 |
51 |
94.44% |
0 | 0 | 0.00% | 28 | 7 | 100.00% | 0 | 0 | 0.00% | 76 | 30 | 93.75% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 87 | 17 | 94.44% | 0 | 0 | 0.00% |
Click to Show Other Adverse Events Details
|
|
Anxiety |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 16.67% | 0 | 0 | 0.00% |
Bradykinesia |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 8 | 2 | 11.11% | 0 | 0 | 0.00% |
Depression |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 9.38% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Dysarthria |
0 | 0 | 0.00% | 5 | 2 | 28.57% | 0 | 0 | 0.00% | 6 | 5 | 15.62% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 13 | 6 | 33.33% | 0 | 0 | 0.00% |
Dyskinesias |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.11% | 0 | 0 | 0.00% |
Dystonia |
0 | 0 | 0.00% | 2 | 1 | 14.29% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 5 | 2 | 11.11% | 0 | 0 | 0.00% |
Exacerbation of Tics |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 16.67% | 0 | 0 | 0.00% |
Gait Disorder |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 6.25% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Lethargy |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 4 | 4 | 12.50% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 1 | 5.56% | 0 | 0 | 0.00% |
Muscle Contractions |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.11% | 0 | 0 | 0.00% |
Nausea or Vertigo |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 7 | 7 | 21.88% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Obsessive-Compulsive Behaviors (new or exacerbated) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.11% | 0 | 0 | 0.00% |
Other |
0 | 0 | 0.00% | 6 | 2 | 28.57% | 0 | 0 | 0.00% | 31 | 19 | 59.38% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 43 | 12 | 66.67% | 0 | 0 | 0.00% |
Paresthesias |
0 | 0 | 0.00% | 3 | 3 | 42.86% | 0 | 0 | 0.00% | 10 | 8 | 25.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 11.11% | 0 | 0 | 0.00% |
Pulse Generator Removal |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 2 | 6.25% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Weight Gain (>10 pounds) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 9.38% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Click to Hide Other Adverse Events Details
|
Other Adverse Events Details do not include the single instance events
|
|
All Targets |
n ( # ) |
Number of adverse events by category (where # is total number of adverse events). |
subjects ( # ) |
Number of subjects with an adverse event by category (where # is total number of subjects with leads). |
% {Total Cohort} |
Total number of leads with an adverse event out of total subjects. |
|
Individual Target |
n ( # ) |
Number of adverse events by category for the target (where # is total number of adverse events for the target). |
subjects ( # ) |
Number of participants with an adverse event and the target by category (where # is total number of participants with the target). |
% |
Percent of total number of participants with the target by category. |
|
Explants |
10 |
9 |
15.79% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 7 | 6 | 17.65% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 15.79% | 0 | 0 | 0.00% |
Infections |
8 |
7 |
12.28% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 8 | 7 | 20.59% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Hemorrhages |
2 |
2 |
3.51% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 2.94% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 5.26% | 0 | 0 | 0.00% |
Programming Related |
184 |
45 |
78.95% |
0 | 0 | 0.00% | 25 | 3 | 42.86% | 0 | 0 | 0.00% | 63 | 23 | 67.65% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 96 | 19 | 100.00% | 0 | 0 | 0.00% |
Other Adverse Events |
198 |
52 |
91.23% |
0 | 0 | 0.00% | 36 | 7 | 100.00% | 0 | 0 | 0.00% | 77 | 31 | 91.18% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 95 | 17 | 89.47% | 0 | 0 | 0.00% |
Click to Show Other Adverse Events Details
|
|
Anxiety |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 15.79% | 0 | 0 | 0.00% |
Bradykinesia |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 10 | 2 | 10.53% | 0 | 0 | 0.00% |
Depression |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 8.82% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Dysarthria |
0 | 0 | 0.00% | 7 | 2 | 28.57% | 0 | 0 | 0.00% | 6 | 5 | 14.71% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 13 | 6 | 31.58% | 0 | 0 | 0.00% |
Dyskinesias |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Dystonia |
0 | 0 | 0.00% | 4 | 1 | 14.29% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 7 | 3 | 15.79% | 0 | 0 | 0.00% |
Exacerbation of Tics |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 15.79% | 0 | 0 | 0.00% |
Gait Disorder |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 2 | 2 | 5.88% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Lethargy |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 4 | 4 | 11.76% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 1 | 5.26% | 0 | 0 | 0.00% |
Muscle Contractions |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Nausea or Vertigo |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 7 | 7 | 20.59% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Obsessive-Compulsive Behaviors (new or exacerbated) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Other |
0 | 0 | 0.00% | 8 | 2 | 28.57% | 0 | 0 | 0.00% | 32 | 20 | 58.82% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 47 | 12 | 63.16% | 0 | 0 | 0.00% |
Paresthesias |
0 | 0 | 0.00% | 3 | 3 | 42.86% | 0 | 0 | 0.00% | 10 | 8 | 23.53% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Pulse Generator Removal |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 2 | 5.88% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Weight Gain (>10 pounds) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 8.82% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Click to Hide Other Adverse Events Details
|
Other Adverse Events Details do not include the single instance events
|
|
All Targets |
n ( # ) |
Number of adverse events by category (where # is total number of adverse events). |
subjects ( # ) |
Number of subjects with an adverse event by category (where # is total number of subjects with leads). |
% {Total Cohort} |
Total number of leads with an adverse event out of total subjects. |
|
Individual Target |
n ( # ) |
Number of adverse events by category for the target (where # is total number of adverse events for the target). |
subjects ( # ) |
Number of participants with an adverse event and the target by category (where # is total number of participants with the target). |
% |
Percent of total number of participants with the target by category. |
|
Explants |
13 |
12 |
18.46% |
1 | 1 | 33.33% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 10 | 9 | 21.95% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 15.79% | 0 | 0 | 0.00% |
Infections |
13 |
12 |
18.46% |
2 | 2 | 66.67% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 12 | 11 | 26.83% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Hemorrhages |
2 |
2 |
3.08% |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 2.44% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 1 | 1 | 5.26% | 0 | 0 | 0.00% |
Programming Related |
235 |
52 |
80.00% |
7 | 3 | 100.00% | 40 | 3 | 42.86% | 0 | 0 | 0.00% | 77 | 29 | 70.73% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 116 | 19 | 100.00% | 0 | 0 | 0.00% |
Other Adverse Events |
242 |
59 |
90.77% |
4 | 3 | 100.00% | 51 | 7 | 100.00% | 0 | 0 | 0.00% | 85 | 37 | 90.24% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 115 | 17 | 89.47% | 0 | 0 | 0.00% |
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Anxiety |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 15.79% | 0 | 0 | 0.00% |
Bradykinesia |
0 | 0 | 0.00% | 4 | 1 | 14.29% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 17 | 2 | 10.53% | 0 | 0 | 0.00% |
Depression |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 7.32% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Dysarthria |
0 | 0 | 0.00% | 9 | 2 | 28.57% | 0 | 0 | 0.00% | 6 | 5 | 12.20% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 18 | 6 | 31.58% | 0 | 0 | 0.00% |
Dyskinesias |
0 | 0 | 0.00% | 2 | 1 | 14.29% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Dystonia |
0 | 0 | 0.00% | 5 | 1 | 14.29% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 10 | 4 | 21.05% | 0 | 0 | 0.00% |
Exacerbation of Tics |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 15.79% | 0 | 0 | 0.00% |
Gait Disorder |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 2 | 2 | 4.88% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Lethargy |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 4 | 4 | 9.76% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 1 | 5.26% | 0 | 0 | 0.00% |
Muscle Contractions |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 2 | 10.53% | 0 | 0 | 0.00% |
Nausea or Vertigo |
0 | 0 | 0.00% | 2 | 2 | 28.57% | 0 | 0 | 0.00% | 8 | 8 | 19.51% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Obsessive-Compulsive Behaviors (new or exacerbated) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Other |
3 | 2 | 66.67% | 14 | 2 | 28.57% | 0 | 0 | 0.00% | 35 | 22 | 53.66% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 51 | 12 | 63.16% | 0 | 0 | 0.00% |
Paresthesias |
0 | 0 | 0.00% | 3 | 3 | 42.86% | 0 | 0 | 0.00% | 10 | 8 | 19.51% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 2 | 2 | 10.53% | 0 | 0 | 0.00% |
Pulse Generator Removal |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 6 | 5 | 12.20% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
Weight Gain (>10 pounds) |
0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 3 | 3 | 7.32% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% | 0 | 0 | 0.00% |
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Other Adverse Events Details do not include the single instance events
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All Targets |
n ( # ) |
Number of adverse events by category (where # is total number of adverse events). |
subjects ( # ) |
Number of subjects with an adverse event by category (where # is total number of subjects with leads). |
% {Total Cohort} |
Total number of leads with an adverse event out of total subjects. |
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Individual Target |
n ( # ) |
Number of adverse events by category for the target (where # is total number of adverse events for the target). |
subjects ( # ) |
Number of participants with an adverse event and the target by category (where # is total number of participants with the target). |
% |
Percent of total number of participants with the target by category. |
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