BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3177624 · Received June 5, 2007

    Report

    Report Number
    6000030-2007-01916
    Event Type
    Malfunction
    Date Received
    June 5, 2007
    Report Date
    May 21, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2006 THE PT DEVELOPED LIVER FAILURE AND ASCITIS; THE PUMP POCKET KEPT FILLING WITH FLUID. THE PHYSICIAN DID NOT BELIEVE THE POCKET FLUID WAS RELATED TO THE ASCITIS OR TO THE LIVER FAILURE. DURING DEVICE EXPLANT THEY FOUND "THE PUMP FLIPPING AROUND IN THE POCKET AND FLUID AROUND THE PUMP THAT THE REFILL DOCTOR REFUSED TO REMOVE ANY LONGER," THE CATHETER WAS FOUND DISCONNECTED FROM THE PUMP. THE PT REPORTED THEY HAD EXPERIENCED NO PAIN RELIEF FROM THE PUMP THERAPY; THE PT FEELS BETTER SUBSEQUENT TO HAVING THE PUMP REMOVED. THE DRUG USED IN THE PUMP IS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN. SEE MFR REPORT NUMBER 6000030-2007-01917.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 862618 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL: UNK, LOT # UNK| CATHETER: MODEL: 8703W, LOT #L56471| EXPLANTED:| IMPLANTED: