FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1833131
·
Received September 3, 2010
Report
- Report Number
- 3004209178-2010-06760
- Event Type
- Death
- Date Received
- September 3, 2010
- Date of Event
- August 6, 2010
- Report Date
- August 6, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- 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
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A PT DEATH ON (B)(6)2010, CAUSE OF DEATH UNK. PT WAS FOUND AT HOME. IT WAS UNK IF THE DEVICE WAS RELATED TO THE DEATH. PT WAS IMPLANTED ON (B)(6)2010, IN THE MORNING. PRIMING BOLUS OF 0.443ML WAS PROGRAMMED OVER 30MIN DURATION. PUMP TUBE PLUS CATHETER VOLUME WAS 0.199ML + 0.229ML. AN ADDITIONAL 0.15ML BOLUS WAS ADDED TO THE PRIME FOR A TOTAL PRIME VOLUME OF 0.443ML. DAILY DOSE WAS PROGRAMMED AT 0.5MG/DAY OF 10MG/ML CONCENTRATION OF MORPHINE. NO PRIMING BOLUS WAS PERFORMED ON THE BACK TABLE. IT IS UNCERTAIN IF THE PUMP WILL BE RETURNED BECAUSE THE DEPUTY CORONER ON THE CASE IS HESITANT. ADDITIONAL INFO 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# N259095011 |