FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1150166
·
Received September 3, 2008
Report
- Report Number
- 2182207-2008-05396
- Event Type
- Death
- Date Received
- September 3, 2008
- Date of Event
- June 15, 2008
- Report Date
- August 5, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPIRED. THE CAUSE OF DEATH IS UNK. THE DEATH WAS REPORTEDLY UNRELATED TO THE IMPLANTED SYSTEM. THE DRUG USED IN THE PUMP WAS HYDROMORPHONE 3.0 MG/ML AT A DOSE OF 1.7477 MG/DAY AND BUPIVACAINE 25 MG/ML (DOSE NOT REPORTED).
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 | 88 YR | Death| L | PROGRAMMER MODEL 8840| EXPLANTED| IMPLANTED| CATHETER MODEL 8709 |