FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM LEAD
MDR report key: 1032941
·
Received April 23, 2008
Report
- Report Number
- 2182207-2008-02153
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Report Date
- March 25, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE PT REPORTED THAT SHE WAS FEELING NO STIMULATION FROM HER DEVICE AND HADN'T FELT ANY FOR MOS. TROUBLESHOOTING REVEALED THAT THE DEVICE WAS NOT RESPONDING TO THE PT PROGRAMMER. SHE STATES THAT SHE VISITED HER PHYSICIAN AND IT WAS CONFIRMED THAT THERE WAS AN ISSUE WITH HER LEAD AND THOUGH HER DEVICE IS TURNED OFF, SHE FEELS SHOCKING SENSATIONS. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM LEAD | EZW | MEDTRONIC NEUROMODULATION | 3080 | L51781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| IPG MODEL 7424| EXPLANTED:| EXTENSION MODEL 3095| IMPLANTED: |