FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1062343
·
Received June 18, 2008
Report
- Report Number
- 6000030-2008-03337
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- April 9, 2008
- Report Date
- May 20, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL PUMP FUNCTION. FINAL CATHETER ANALYSIS REVEALED A HOLE IN THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THE PT UNDERWENT REPLACEMENT SURGERY INCLUDING THE PUMP AND CATHETER, DUE TO NORMAL DEVICE END OF LIFE. THE CONCENTRATION, DOSE, AND DRUG IN THE PUMP WERE NOT REPORTED. NO SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | EXPLANTED| PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL 8703 |