FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 478448
·
Received August 13, 2003
Report
- Report Number
- 6000030-2003-00726
- Event Type
- Malfunction
- Date Received
- August 13, 2003
- Date of Event
- August 1, 2003
- Report Date
- August 11, 2003
- Manufacturer
- RICE CREEK MFG.
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THE PT WAS EXPERIENCING DECREASED PAIN RELIEF AND THAT THEY REMOVED 18CC OF MORPHINE FROM THE PUMP AT REFILL. ROTOR STUDIES WERE DONE WHICH THE PUMP FAILED MULTIPLE TIMES. "PUMP ROTOR DIDN'T TURN 90 DEGREES." THE PUMP WAS EXPLANTED AND REPLACED AND RETURNED TO THE MFR FOR ANALYSIS. THE PT OUTCOME WAS NOT REPORTED. A FOLLOW UP REPORT WILL BE SENT WHEN ADD'L INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MFG. | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization | CATHETER MODEL 8709 LOT# J11455R14 IMPLANTED 2003,| EXPLANTED: UNK. |