FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2925892
·
Received January 22, 2013
Report
- Report Number
- 3004209178-2013-00857
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Report Date
- January 3, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3093-28, LOT# V620566, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SHE TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) ON. THE PATIENT'S AMPLITUDE WAS AT 5V PRIOR TO THE REPORT BUT WAS LOWERED TO 1.5V AT THE TIME OF THE REPORT. THE REPORTER INDICATED THAT THE PATIENT WAS STILL IN SOME PAIN FROM THE STIMULATION BEING SO HIGH BEFORE. THE PATIENT WAS THEREFORE GOING TO WAIT TO TRY IT AGAIN LATER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29800 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |