FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2775300
·
Received October 8, 2012
Report
- Report Number
- 3004209178-2012-08963
- Event Type
- Malfunction
- Date Received
- October 8, 2012
- Report Date
- September 10, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V900199, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNING OFF. WHEN THE PATIENT TURNED STIMULATION UP IT WOULD HURT. THE PATIENT'S DOCTOR INSTRUCTED HIM TO TURN STIMULATION OFF DUE TO A GENITAL PROBLEM HE WAS EXPERIENCING. ADDITIONAL INFORMATION 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 | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |