FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2255221
·
Received August 18, 2011
Report
- Report Number
- 3004209178-2011-06553
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 29, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A 3095-10 EXTENSION WITH SERIAL NUMBER (B)(4) AND A USE BY DATE OF JULY 23, 2011 WAS IMPLANTED IN A PATIENT ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031, LOT# NBW005343P| EXTENSION: MODEL 3095, LOT# NAH036539V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V390180 |