FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2873858
·
Received December 14, 2012
Report
- Report Number
- 3004209178-2012-11838
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Report Date
- November 26, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3093-28, LOT # V272019, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED A SOCKING SENSATION. IT WAS REPORTED THAT THE PATIENT FELT LIKE THE "WIRES" WERE TOO CLOSE TO HIS SKIN. THE PATIENT TURNED THE DEVICE OFF BECAUSE HE WAS FEELING A "STRONG SENSATION WHERE HE COULDN'T STAND IT." IT WAS REPORTED THAT THE PATIENT FELT A BURNING SENSATION AT THE LEAD LOCATION. IT WAS NOTED THAT THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THE PATIENT'S STATUS AT THE TIME OF THIS REPORT WAS STATED AS ALIVE WITH INJURY. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.
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 |