FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1950055
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-10279
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Report Date
- December 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION OCCASIONALLY (USUALLY EVERY 2-3 MONTHS) AS WELL AS CRAMPING IN BOTH BIG TOES WHEN STIMULATION WAS ON. THE TOE CRAMPING HAD BEEN OCCURRING FOR 2-3 YRS. THE PT HAD HER DEVICE RE-PROGRAMMED, BUT THE ISSUES DID NOT RESOLVE. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT # NAH005491N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3080, LOT # L81352 |