FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1181465
·
Received September 30, 2008
Report
- Report Number
- 3004209178-2008-06242
- Event Type
- Death
- Date Received
- September 30, 2008
- Date of Event
- October 17, 2007
- Report Date
- September 2, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DIED IN 2007. THE CAUSE OF DEATH WAS NOT KNOWN. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT REPORTED.
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| EXPLANTED| PROGRAMMER MODEL 8840 LOT#UNK| CATHETER MODEL 8711 LOT#N086721017 |