FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2211101
·
Received August 8, 2011
Report
- Report Number
- 3004209178-2011-06137
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON AND OFF THERE WAS A SHOCKING OR JOLTING SENSATION. REPORTEDLY, THE PATIENT FELL QUITE OFTEN DUE TO MULTIPLE SCLEROSIS. THE SHOCKING SYMPTOM WAS SIMILAR TO WHAT SHE PREVIOUSLY EXPERIENCED WITH HER OLD INS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V032395| PROGRAMMER: MODEL 3037, LOT# NJD043687N |