FDA Adverse Event
Summary report: N
SACRAL NERVE STIMULATION DEVICES
MDR report key: 921655
·
Received September 21, 2007
Report
- Report Number
- 2182207-2007-03036
- Date Received
- September 21, 2007
- Report Date
- April 26, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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. ET AL. "OUTCOME AND COST ANALYSIS OF SACRAL NERVE STIMULATION FOR FAECAL INCONTINENCE: BRITISH JOURNAL OF SURGERY. NOV 2006; 93 (11): 1411-7. THE ARTICLE DESCRIBED A STUDY INVOLVING 36 PATIENTS WHO UNDERWENT A TWO STAGE SNS PROCEDURE FOR FECAL INCONTINENCE. REPORTABLE EVENTS: MODEL 3095 LEAD EXTENSIONS (N=3) - THREE PATIENTS EXPERIENCED INFECTIONS DURING THE SCREENING PHASE AND ALL REQUIRED LEAD EXTENSION REMOVAL AND TREATMENT WITH ANTIBIOTICS. MODEL 3023 IPG (N=2) AND LEAD (N=2) - TWO PATIENTS EXPERIENCED INFECTION THAT REQUIRED THE SYSTEMS TO BE EXPLANTED (IPG AND LEAD).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SACRAL NERVE STIMULATION DEVICES | EZW | MEDTRONIC NEUROMODULATION | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |