FDA Adverse Event
Death
Summary report: N
SYNCHROMED EL
MDR report key: 1150167
·
Received September 3, 2008
Report
- Report Number
- 6000030-2008-05399
- Event Type
- Death
- Date Received
- September 3, 2008
- Date of Event
- July 12, 2008
- Report Date
- August 8, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT EXPIRED; THE CAUSE OF DEATH WAS NOT PROVIDED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNRELATED TO THE IMPLANTED SYSTEM. THE PUMP WAS USED TO DELIVERY MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death | IMPLANTED| CATHETER MODEL 8703W| PROGRAMMER MODEL PROGRAMMER| EXPLANTED |