FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 938175
·
Received November 5, 2007
Report
- Report Number
- 2182207-2007-03690
- Event Type
- Injury
- Date Received
- November 5, 2007
- Report Date
- October 3, 2007
- Manufacturer
- NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P790004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(SEE SCANNED PAGES).
Description of Event or Problem · 1
JOURNAL REFERENCE: HOLZER, B., ET AL. "SACRAL NERVE STIMULATION FOR NEUROGENIC FAECAL INCONTINENCE" BRITISH JOURNAL OF SURGERY, 2007, 94, P 749-53. THE STUDY ASSESSED THE VALUE OF SNS IN A COHORT OF PATIENTS WITH FAECAL INCONTINENCE OF NEUROGENIC ORIGIN. A BENEFICIAL EFFECT WAS SEEN IN SOME PATIENTS. TWO PATIENTS DEVELOPED A SEVERE INFECTION OF THEIR SYSTEMS; THEY WERE TREATED BY EXPLANTING THE LEAD AND GENERATOR AND DRAINING THE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | EZW | NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | 2 IMPLANTABLE LEADS| 1 IMPLANTABLE IPG |