FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 471589
·
Received July 8, 2003
Report
- Report Number
- 6000030-2003-00565
- Event Type
- Malfunction
- Date Received
- July 8, 2003
- Date of Event
- June 4, 2003
- Report Date
- June 6, 2003
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP STATES THE PATIENT WAS GRADUALLY HAVING THE PUMP RATE INCREASED DUE TO A DECREASE IN PAIN CONTROL. THERE WAS NOT ANY WITHDRAWAL SYMPTOMS. PATIENT THEN HAD A VOLUME DISCREPANCY AT REFILL IN 05/2003-ALL 18CC OF MEDICATION WERE STILL IN THE PUMP. A ROTOR STUDY WAS DONE IN 05/2003 WHICH SHOWED NO ROTOR MOVEMENT. DYE STUDY DONE-UNK DATE OR RESULTS. THE PUMP WAS THEN EXPLANTED ON 2003, THE PATIENT IS REPORTED TO BE HAVING GOOD PAIN RELIEF AND "ALL THE PROBLEMS HAVE RESOLVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MANUFACTURING | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Hospitalization | EXPLANTED: UNK| CATHETER MODEL 8711. LOT# J10944R55. IMPLANT: 2001 |