FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1852135
·
Received September 29, 2010
Report
- Report Number
- 3004209178-2010-07413
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 31, 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
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
STARTING 2 WEEKS AGO, A PT WAS EXPERIENCING A "PULSATING" VS A "TWITCHING" SENSATION IN REGARDS TO A CHANGE OF STIMULATION. IT WAS FURTHER REPORTED THAT THE PT COULD FEEL "THE WIRE", JUST LIKE SHE DID WHEN HER LEAD HAD FRACTURED DUE TO A PREVIOUS FALL. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT (I.E. NO FALL/TRAUMA, OR CHANGE IN ACTIVITY). THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
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 | 50 YR | EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD106269N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V452170| IMPLANTED: |