FDA Adverse Event
Death
Summary report: N
SYNCHROMED EL
MDR report key: 1161171
·
Received September 15, 2008
Report
- Report Number
- 6000030-2008-05727
- Event Type
- Death
- Date Received
- September 15, 2008
- Date of Event
- October 16, 2007
- Report Date
- August 18, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- 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 MORPHINE SULFATE 20 MG/DL; BUPIVICAINE 40 MG/DL; CLONIDINE 200 MCG/ML, DROPERIDOL 150 MCG/DL AND COMPOUNDED BACLOFEN 100 MCG/ML. THE INFUSION RATE WAS 0.5 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death | PROGRAMMER| CATHETER MODEL 8709| EXPLANTED| IMPLANTED |