FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2429331
·
Received January 26, 2012
Report
- Report Number
- 3004209178-2012-00545
- Event Type
- Injury
- Date Received
- January 26, 2012
- Report Date
- January 18, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: EXTENSION MODEL 3095-10 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: UNKNOWN, LEAD MODEL 3889-28 LOT# V05 1852 IMPLANTED: (B)(6) 2007 EXPLANTED: UNKNOWN, PROGRAMMER MODEL 3037 SERIAL# (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD ALL HER DEVICE COMPONENTS REMOVED BECAUSE HER BODY WAS NOT ABLE TO FIGHT OFF AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |