FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1144026
·
Received August 29, 2008
Report
- Report Number
- 3004209178-2008-05335
- Event Type
- Death
- Date Received
- August 29, 2008
- Date of Event
- July 19, 2008
- Report Date
- August 1, 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 UNK. THE REPORTER INDICATED THAT THE DEATH WAS UNRELATED TO THE IMPLANTED SYSTEM. THE PUMP CONTAINED FENTANYL 2000 MCG/ML; BUPIVICAINE 40 MG/ML; DROPERIDOL 450 MCG/ML, COMPOUNDED BACLOFEN 450 MCG/ML AND HYDROMORPHONE 15 MG/ML INFUSED AT A RATE OF 1 ML/DAY.
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 | Death | IMPLANTED| IMPLANTED| EXPLANTED| CATHETER MODEL 8709SC LOT# N130923018| PROGRAMMER MODEL 8832 LOT# NJG004961N| EXPLANTED| CATHETER MODEL 8598A LOT# N121882004 |