FDA Adverse Event
Other
Summary report: N
SACRAL NERVE STIMULATION DEVICES
MDR report key: 921659
·
Received September 21, 2007
Report
- Report Number
- 2182207-2007-03041
- Event Type
- Other
- Date Received
- September 21, 2007
- Report Date
- June 14, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION.
Description of Event or Problem · 1
JOURNAL REFERENCE: HETZER, F.H. ET AL. " SACRAL NERVE STIMULATION IN THE TREATMENT OF FECAL INCONTINENCE." SCHWEIZERISCHE RUNSCHAU FUR MEDIZIN- PRAXIS 27 APR 2005; 94/17(681-686). THE ARTICLE DESCRIBES A STUDY OF 25 PTS (16 PERMANENT IMPLANTS) BEING TREATEND WITH SACRAL NERVE STIMULATION OF FECAL INCONTINENCE. REPORTABLE EVENTS INCLUDE: 1. LEAD (N=1) ONE PT EXPERIENCED AN INFECTION AT THE ELECTRODE SITE DURING THE SCREENING PHASE. 2. 3023 IPG (N=1) - ONE PT EXPERIENCED A SEROMA AT THE SITE OF THE IPG IMPLANT. SURGERY WAS REQUIRED TO CORRECT THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SACRAL NERVE STIMULATION DEVICES | EZW | MEDTRONIC NEUROMODULATION | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |