FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1070460
·
Received July 7, 2008
Report
- Report Number
- 6000030-2008-03800
- Event Type
- Malfunction
- Date Received
- July 7, 2008
- Date of Event
- May 30, 2008
- Report Date
- May 30, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULT CODE - CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PUMP REPLACEMENT PROCEDURE THE HCP WAS UNABLE TO ASPIRATE THE CATHETER. THE HCP CUT OFF THE PUMP CONNECTOR BUT WAS STILL UNABLE TO ASPIRATE THE CATHETER. THE HCP ATTEMPTED TO INJECT DYE INTO THE CATHETER BUT WAS UNABLE. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8626 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | CATHETER MODEL 8711 LOT #J0056622R IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT #UNKNOWN |