FDA Adverse Event
Death
Summary report: N
SOLETRA
MDR report key: 1421604
·
Received July 23, 2009
Report
- Report Number
- 6000032-2009-05089
- Event Type
- Death
- Date Received
- July 23, 2009
- Report Date
- June 26, 2009
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED. THE PT HAD MULTIPLE HEALTH ISSUES. THE CAUSE OF DEATH WAS NOT BELIEVED TO BE ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR DEVICES. THE PT'S PHYSICIAN WAS NOT AWARE OF ANY HEALTH PROBLEMS. REFER TO MFR'S REPORT# 6000032-2009-05088.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO, MED REL | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | EXTENSION: MODEL 7482| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NFW110368H| IMPLANTED:| LEAD: MODEL 3389| IMPLANTED:| LEAD: MODEL 3389| IMPLANTED: |