FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 3191769
·
Received June 26, 2013
Report
- Report Number
- 9614453-2013-01456
- Event Type
- Injury
- Date Received
- June 26, 2013
- Date of Event
- December 2, 2005
- Report Date
- May 4, 2006
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 30932843, LOT# B0359616K, IMPLANTED: 2005-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 30951043, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD POOR FUNCTION AT THE GASTROINTESTINAL TRACT AFTER IMPLANTATION AND THIS WAS NOT POSSIBLE TO CORRECT WITH REPROGRAMMING. THERE WAS MALFUNCTION OF THE PERMANENT LEAD. THE DATE OF EXPLANT WAS UNABLE TO BE OBTAINED AND PATIENT STATUS WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290239 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | IPG MFG SWITZERLAND | 302343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00031 YR | Required Intervention |