FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1060701
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03206
- Event Type
- Death
- Date Received
- June 13, 2008
- Date of Event
- March 21, 2008
- Report Date
- May 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR DISPOSAL ONLY. NO CLINICAL OR DEVICE INFO WAS PROVIDED. THE PT DIED THE DATE OF DEVICE IMPLANT PER SOCIAL SECURITY ADMIN DEATH FILE (NOTED IN DEVICE TRACKING). THE PUMP WAS USED TO DELIVER DILAUDID, BUPIVACAINE, AND DROPERIDOL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
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| PROGRAMMER MODEL 8840 LOT # UNK| EXPLANTED| CATHETER MODEL 8709 LOT# N138505023 |