FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2251101
·
Received September 8, 2011
Report
- Report Number
- 3004209178-2011-07579
- Event Type
- Malfunction
- Date Received
- September 8, 2011
- Date of Event
- September 1, 2011
- Report Date
- September 2, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT STIMULATION COULD NOT BE ADJUSTED, AND THE DISPLAY WAS SHOWING THE "CALL YOUR DOCTOR" ICON. THERE WAS A POWER ON RESET CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | PROGRAMMER: MODEL 3037, LOT# NJD096510N| IMPLANTED:| LEAD: MODEL 3093, LOT# V360240| EXPLANTED: |