FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2062831
·
Received March 25, 2011
Report
- Report Number
- 3004209178-2011-02108
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 9, 2011
- 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
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT NEVER EXPERIENCED THERAPEUTIC EFFECT. A MESSAGE ON THE PT PROGRAMMER INDICATED THAT THE NEUROSTIMULATOR WAS AT END OF SERVICE (EOS). ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 | 63 YR | LEAD: MODEL 3093, LOT# V240181| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD084288N |