FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1220329
·
Received November 4, 2008
Report
- Report Number
- 3004209178-2008-07189
- Event Type
- Death
- Date Received
- November 4, 2008
- Date of Event
- February 22, 2008
- Report Date
- October 7, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATENT EXPIRED. THE PATIENT WAS LAST SEEN IN THE CLINIC IN 2008. THE PATIENT HAD METASTATIC COLON CANCER. THE PUMP CONTAINED MORPHINE SULFATE 5 MG/ML AND BUPIVICAINE 14 MG/ML AT AN INFUSION RATE OF 0.649 ML. THE CAUSE OF DEATH WAS NOT REPORTED; IT WAS REPORTED TO BE UNRELATED TO THE IMPLANTED SYSTEM.
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 | PROGRAMMER: MODEL 8832| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840 |