FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1213783
·
Received October 22, 2008
Report
- Report Number
- 3004209178-2008-06737
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER THE PT HAD A "PACER" PUT IN, WHEN SHE TURNED THE STIMULATION ON, SHE FELT SHOCKING AND NUMBNESS IN HER LIP. WHEN THE STIMULATOR WAS TURNED OFF, IT WAS FINE; IT ONLY HAPPENED WHEN THE STIMULATOR WAS TURNED ON. IT WAS RECOMMENDED THAT THE PT'S MANAGING PHYSICIAN BE CONTACTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN| EXTENSION: MODEL 7482 |