31
The following table depicts the number of patients, the number of events observed, and the
percentage of occurrences of each event compared to the total number of patients. It should be
noted that several studies include both IPG and RF systems. The clinical experience reported in
the literature on RF systems is relevant to determining the safety of totally implantable IPG
systems.
Table 16. Summary of risks identified in the retrospective clinical studies
Risks
Number of Patients
Number of Events
Percent of Patients
Lead migration
1059
144
13.6
Infection
1253
37
3.0
Epidural hemorrhage
1253
0
0
Seroma
1253
0
0
Hematoma
1253
5
0.4
Paralysis
1253
1
0.1
CSF leak
1253
6
0.5
Over/under stim
1059
27
2.6
Intermittent stim
1059
0
0
Pain over implant
1059
12
1.1
Allergic reaction
1059
2
0.2
Skin erosion
1059
1
0.1
Lead breakage
1059
182
17.2
Hardware malfunction
1059
32
3.0
Loose connection
1059
10
1.0
Battery failure
911
17
1.9
Other
1059
24
2.3
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