INTERSTIM II
Report
- Report Number
- 3004209178-2012-10263
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Report Date
- October 16, 2012
- 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 3889-28, LOT#: V872659, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD "SEVERE" PAIN IN HER RIGHT SIDE, WHERE THE IMPLANT WAS LOCATED, FOR A "COUPLE" MONTHS PRIOR TO THE REPORT. THE PAIN STARTED IN (B)(6) AND THEN SHE TURNED THE IMPLANT OFF IN (B)(6). THE PATIENT'S DEVICE HAD BEEN OFF SINCE (B)(6) BECAUSE IT WAS MAKING HER LEFT LEG "COMPLETELY NUMB" THE PATIENT STATED HER DEVICE WAS WORKING "FINE" UNTIL A "COUPLE" MONTHS AGO. THE PATIENT WAS TAKING PAIN MEDICATION AND TRIED A HEATING PAD FOR PAIN. THE PATIENT REPORTED SHE WAS NOT A VERY "STURDY" PERSON AND HAD FALLEN "SEVERAL/FIVE TIMES" WITHIN THE PAST "SEVERAL/COUPLE" MONTHS AND THAT WAS WHEN "SOME" OF HER ISSUES STARTED. THE PATIENT TWISTED HER ANKLE TWICE TO THE POINT WHERE IT "POPPED" OUT. THE PATIENT ALSO STATED SHE LOST "A LOT" OF WEIGHT, "OVER 50 POUNDS", IN THE PAST "FEW" MONTHS. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS "POKING OUT OF HER SKIN SOMETIMES". ADDITIONAL INFORMATION WAS 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 | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |