FDA Adverse Event
Malfunction
Summary report: N
MATTRIX
MDR report key: 1993789
·
Received January 13, 2011
Report
- Report Number
- 3007566237-2011-00335
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- December 27, 2010
- Report Date
- December 30, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- K934065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AT REPLACEMENT, THE OLD IMPLANTABLE DEVICE WAS COMPLETELY CORRODED. IT WAS NOTED THAT THE PT HAD FALLEN, BUT THEY WERE UNSURE IF THIS WAS WHAT CAUSED THE EXTREME DAMAGE TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATTRIX | GZB | MEDTRONIC NEUROMODULATION | 3272 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# L43443| LEAD: MODEL 3487A, LOT# L43443| TRANSMITTER: MODEL 3210, LOT# NBU004487P| EXPLANTED:| EXPLANTED: |