FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1344997
·
Received March 16, 2009
Report
- Report Number
- 2182207-2009-01814
- Event Type
- Death
- Date Received
- March 16, 2009
- Date of Event
- February 14, 2009
- Report Date
- February 16, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP AND CATHETER WERE RETURNED FOR ANALYSIS. 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 EXPIRED. THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE. NO CAUSE OF DEATH WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death | CATHETER: MODEL 8709| PROGRAMMER: MDOEL 8840| EXPLANTED: |