FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1161168
·
Received September 15, 2008
Report
- Report Number
- 3004209178-2008-05732
- Event Type
- Death
- Date Received
- September 15, 2008
- Date of Event
- February 20, 2008
- Report Date
- August 18, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED. THE PT HAD A TERMINAL ILLNESS; THE CAUSE OF DEATH WAS NOT REPORTED. PER THE REPORTER, THE DEATH WAS UNRELATED TO THE IMPLANTED DEVICE. THE PUMP CONTAINED HYDROMORPHONE 1.0 MG/ML; BUPIVICAINE 40 MG/ML; CLONIDINE 350 MCG/ML; COMPOUNDED BACLOFEN 500 MCG/ML AND KETAMINE 400 MCG/ML. THE INFUSION RATE WAS 1.5 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death | IMPLANTED| CATHETER MODEL 8709| EXPLANTED| PROGRAMMER MODEL 8832 |