FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1211218
·
Received October 24, 2008
Report
- Report Number
- 2182207-2008-06872
- Event Type
- Death
- Date Received
- October 24, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 26, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE EVENT DATE. THE PATIENT HAD BEEN AT THE CARE CENTER AND WAS HAVING EPISODES OF "HYPOTHERMIA" DUE TO THE AIR CONDITIONING BEING SO COLD. WHEN THE DAUGHTER TOOK THE PATIENT OUTSIDE IN THE WARM AIR, SHE SEEMED TO "PERK UP". AFTER DETERMINING THIS, THE PATIENT'S DAUGHTER MOVED HER TO ANOTHER CARE CENTER. THE PATIENT HAD JUST RECENTLY CALLED ABOUT HER REFILL (WHICH WASN'T DUE UNTIL THE FOLLOWING MONTH). THE DAUGHTER HAD REPORTED THAT THE PATIENT WAS "FINE". A NIECE WAS VISITING HER, HAD LEFT THE ROOM FOR A SHORT TIME AND WHEN SHE RETURNED THE PATIENT HAD DIED. THE CAUSE OF DEATH WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death | CATHETER MODEL CATHETER LOT # UNKNOWN IMPLANTED| PROGRAMMER MODEL 8840 LOT # UNKNOWN| EXPLANTED |