FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1083383
·
Received July 28, 2008
Report
- Report Number
- 6000030-2008-04447
- Event Type
- Malfunction
- Date Received
- July 28, 2008
- Date of Event
- March 1, 2005
- Report Date
- July 7, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CATHETER.
Description of Event or Problem · 1
THE PATIENT REPORTED: "IN 2005 THE CATHETER HAD BECOME DISCONNECTED (INSIDE OF ME), BUT I COULD NOT FIND A DOCTOR WHO WOULD TEST TO DETERMINE THIS." NO SYMPTOMS WERE REPORTED. AN X-RAY TAKEN IN 2008, BEFORE AN ELECTIVE PUMP REPLACEMENT, SHOWED THAT "THE PUMP WAS DISCONNECTED". THE PUMP WAS REPLACED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTH PROFESSIONAL.
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 | 56 YR | Required Intervention | CATHETER MODEL# 8709| IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK |