FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1312379
·
Received February 12, 2009
Report
- Report Number
- 2182207-2009-00905
- Event Type
- Death
- Date Received
- February 12, 2009
- Report Date
- January 15, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN, BUT REPORTED TO BE UNRELATED TO THE DEVICE. IT WAS LATER REPORTED THAT THE CAUSE OF DEATH OR WHETHER THE DEATH WAS ATTRIBUTED TO DEVICE WAS UNKNOWN. THE PT'S DEATH WAS SUSPECTED TO BE FROM NATURAL CAUSES. NO SYMPTOMS WERE REPORTED. THE PUMP CONTAINED LIORESAL; DOSE AND CONCENTRATION NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | IMPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709| EXPLANTED: |