FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 920870
·
Received September 21, 2007
Report
- Report Number
- 2182207-2007-03043
- Event Type
- Injury
- 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 Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED.
Description of Event or Problem · 1
JOURNAL REFERENCE: JARRETT M, ET AL. "SACRAL NERVE STIMULATION FOR FAECAL INCONTINENCE IN PTS WITH PREVIOUS PARTIAL SPINAL INJURY INCLUDING DISC PROLAPSE. "BRITISH JOURNAL OF SURGERY. JUNE 2005; 92 (6) P734-9. THE ARTICLE DESCRIBES A STUDY THAT EXAMINED THE USE OF SACRAL NERVE STIMULATION (SNS) TO TREAT FAECAL INCONTINENCE IN PTS WITH PARTIAL SPINAL INJURY. A TOTAL OF 13 PATIENTS WERE INVOLVED IN THE STUDY. REPORTABLE EVENT: A PT BEING TREATED WITH SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE EXPERIENCED A PAIN, DELAYED HEALING AND HAD SUFFERED TRAUMA AT THE IPG (MODEL 3023) IMPLANT SITE. PROBLEMS WERE RESOLVED WITH REPOSITIONING OF DEVICE, ANALEPSIS AND ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC NEUROMODULATION | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | LEAD| PROGRAMMER| LEAD| PROGRAMMER |