FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1930043
·
Received November 18, 2010
Report
- Report Number
- 3004209178-2010-09776
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 11, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- 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
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NOTICED THAT THE DEVICE WAS NOT WORKING FOLLOWING A FALL ON ICE LAST WINTER. SPECIFICALLY, SHE WAS GOING TO THE BATHROOM 6 TO 8 TIMES A NIGHT. ADDITIONAL INFO WAS REQUESTED.
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 | EXPLANTED:| EXTENSION: MODEL 3095, LOT #: NAH028600V| PROGRAMMER: MODEL 3031A, LOT #: NGM026946P| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT #: V003431 |