FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2062461
·
Received April 12, 2011
Report
- Report Number
- 3004209178-2011-02770
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- July 1, 2010
- Report Date
- April 4, 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
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAS A LOSS OF THERAPEUTIC EFFECT FOLLOWING A HIP REPLACEMENT LAST SUMMER. PRIOR TO THE SURGERY, THE PT WAS RECEIVING RELIEF FOR PAIN AND RECTAL SPASMS. THE DEVICE WAS TURNED OFF PRIOR TO THE SURGERY. PER THE REPORTER, THE HEALTH CARE PROFESSIONAL INTERROGATED THE DEVICE WITH THE PT PROGRAMMER AND STATED THERE WAS NOTHING MORE THEY COULD DO AS FAR AS REPROGRAMMING. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 | 70 YR | PROGRAMMER: MODEL 3037, LOT# NJD089182N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V287635 |