FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2101721
·
Received May 11, 2011
Report
- Report Number
- 3004209178-2011-03427
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REC'D INFO THE PT REPORTED A LOSS OF THERAPEUTIC STIMULATION A MONTH AGO. THERE WAS NO ACCIDENT OR INCIDENT RELATED TO THIS EVENT. PT ALSO REQUESTED INFO ABOUT USING THE PT PROGRAMMER AND CONTROL MAGNET. PT WAS INSTRUCTED ON THE BASIC FUNCTIONALITY, NAVIGATING BETWEEN SCREENS AND ADJUSTING PARAMETERS. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D A F/U REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | H0298069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | LEAD: MODEL 3093, LOT# V516939| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD111343N |