FDA Adverse Event
Death
Summary report: N
SYNCRHOMED II
MDR report key: 1140343
·
Received August 28, 2008
Report
- Report Number
- 2182207-2008-05312
- Event Type
- Death
- Date Received
- August 28, 2008
- Date of Event
- July 25, 2008
- Report Date
- July 29, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED. THE CAUSE OF DEATH WAS UNK, BUT WAS REPORTED TO BE UNRELATED TO THE IMPLANTED SYSTEM. THE PT HAD SEVERE SECONDARY, PROGRESSIVE MULTIPLE SCLEROSIS. THE PT WAS RECEIVING BACLOFEN IN THE PUMP VIA SIMPLE CONTINUOUS MODE. THE INFUSION RATE WAS 0.2949 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | PROGRAMMER MODEL 8840| EXPLANTED| IMPLANTED| CATHETER MODEL 8709 |