FDA Adverse Event
Death
Summary report: N
SOLETRA
MDR report key: 1061655
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03205
- Event Type
- Death
- Date Received
- June 13, 2008
- Date of Event
- October 29, 2006
- Report Date
- May 14, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE NEUROSTIMULATOR REVEALED NO SIGNIFICANT ANOMALIES; ASSUME NORMAL END OF LIFE. ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALIES; THE EXTENSION WAS SEGMENTED (SUSPECT EXPLANT DAMAGE).
Description of Event or Problem · 1
IT WAS REPORTED THE PT DIED. FURTHER INVESTIGATION REVEALED NO ISSUES; THE DEVICES WERE RETURNED FOR DISPOSAL ONLY. DESPITE SEVERAL ATTEMPTS TO OBTAIN THE CAUSE OF DEATH, THE MFR WAS UNABLE TO OBTAIN THE CAUSE OF DEATH. REFER TO MEDWATCH REPORT # 3004209178200803207. THE FUNERAL HOME WOULD NOT RELEASE THE CAUSE OF DEATH DUE TO PRIVACY LAWS.
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 | Death | IMPLANTED| EXTENSION MODEL 7482 LOT # NHU064468V| EXPLANTED:| LEAD MODEL 3389| IMPLANTED| EXPLANTED| RIGHT DEEP BRAIN STIMULATION SYSTEM |