FDA Adverse Event
Death
Summary report: N
SYNCHROMED
MDR report key: 1666439
·
Received April 22, 2010
Report
- Report Number
- 3007566237-2010-03255
- Event Type
- Death
- Date Received
- April 22, 2010
- Report Date
- March 25, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. THE DATE AND CAUSE OF DEATH WERE NOT REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK |