FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1061360
·
Received June 17, 2008
Report
- Report Number
- 2182207-2008-03272
- Event Type
- Death
- Date Received
- June 17, 2008
- Date of Event
- May 18, 2008
- Report Date
- May 20, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED. THE CAUSE OF DEATH WAS UNK. IT IS UNK IF AN AUTOPSY WAS PERFORMED. THE PUMP CONTAINED MORPHINE SULFATE 15MG/ML AT A DOSE OF 4.354 MG AND BUPIVICAINE 10 MG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | EXPLANTED| ACCESSORY MODEL 8590-1| EXPLANTED| PROGRAMMER MODEL 8840| CATHETER MODEL 8711 |