Summary Of Risks Identified In The Retrospective Clinical Studies - Abbott Proclaim 3660 Clinician Manual

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
Lead migration
Infection
Epidural hemorrhage
Seroma
Hematoma
Paralysis
CSF leak
Over/under stim
Intermittent stim
Pain over implant
Allergic reaction
Skin erosion
Lead breakage
Hardware malfunction
Loose connection
Battery failure
Other
References
1. Broggi G, Servello D, Dones I, Carbone G. Italian multicentric study on pain treatment with
epidural spinal cord stimulation. Stereotact Funct Neurosurg. 62(1994):273–278.
2. Burchiel KJ, Anderson VC, Brown FD, et al. Prospective, multicenter study of spinal cord
stimulation for relief of chronic back and extremity pain. Spine. 21(1996):2786–2793.
3. Devulder J, De Laat M, Van Basterlaere M. Spinal cord stimulation: a valuable treatment for
chronic failed back surgery patients. J Pain Symptom Manage. 13(1997):296–301.
4. Hassenbusch S, Stanton-Hicks M, Covington EC. Spinal cord stimulation versus spinal
infusion for low back and leg pain. Acta Neurochir. 64(1995):109–115.
5. Kavar B, Rosenfeld JV, Hutchinson A. The efficacy of spinal cord stimulation for chronic
pain. J Clin Neurosci. 7(2000):409–413.
6. Kumar K, Toth C, Nath R, Lang P. Epidural spinal cord stimulation for treatment of chronic
pain—some predictors of success. A 15 year experience. Surg Neurol. 50(1998):110–120.
7. Mazzone P, Rodriguez G, Arrigo A, Nobili F, Pisandi R, Rosadini G. Cerebral haemodynamic
changes induced by spinal cord stimulation in man. Ital J Neurol Sci. 17(1996):55–57.
Number of Patients
1059
1253
1253
1253
1253
1253
1253
1059
1059
1059
1059
1059
1059
1059
1059
911
1059
Number of Events
144
37
0
0
5
1
6
27
0
12
2
1
182
32
10
17
24
31
Percent of Patients
13.6
3.0
0
0
0.4
0.1
0.5
2.6
0
1.1
0.2
0.1
17.2
3.0
1.0
1.9
2.3