FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1890245
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08326
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 27, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE SYMPTOMS REPORTED WERE LOSS OF BLADDER CONTROL. PT HAD MULTIPLE MRI TESTS DONE SINCE IMPLANT AND PROBLEMS STARTED AFTER MRI. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | EXPLANTED:| LEAD: MODEL 3889, LOT# V249002| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD083675N |