FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1201770
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06644
- Event Type
- Death
- Date Received
- October 17, 2008
- Date of Event
- November 22, 2007
- Report Date
- September 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE THAT THERE WAS RESIDUE BUILD-UP IN THE RESERVOIR BELLOWS. THE ANALYST WAS UNABLE TO EASILY INSTALL OR REMOVE LIQUID FROM RESERVOIR. THE PT EXPIRED IN 2007. THE DEVICE WAS RETURNED FOR ANALYSIS ON 2/18/2008.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED. THE DEATH WAS REPORTED TO BE UNRELATED TO THE DEVICE. THE PT HAD A HISTORY OF METASTATIC COLON CANCER. THE PUMP CONTAINED HYDROMORPHONE 2.0 MG/ML AT 0.8812 MG; BUPIVICAINE 40 MG/ML; DROPERIDOL 300 MG/ML IN SIMPLE CONTINOUS MODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR | Death | CATHETER MODEL 8709 LOT# N090853035| PROGRAMMER MODEL 8832 LOT# NJG003742N| IMPLANTED| EXPLANTED |