FDA Adverse Event
Death
Summary report: N
SOLETRA
MDR report key: 1328108
·
Received February 27, 2009
Report
- Report Number
- 3004209178-2009-01412
- Event Type
- Death
- Date Received
- February 27, 2009
- Date of Event
- December 5, 2008
- Report Date
- February 2, 2009
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
THE PRODUCT WAS RETURNED FROM A MORTUARY WITH NO INFORMATION. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATED THE PATIENT HAD EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT # 6000032-2009-01411.
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 | 76 YR | Death | EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT# NFW117125H |