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
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
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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