BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1193421 · Received October 7, 2008

    Report

    Report Number
    6000030-2008-06385
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    February 21, 2008
    Report Date
    September 8, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE PUMP REVEALED A NON-STANDARD NON-CONFORMANCE - DAMAGED CATHETER ACCESS PORT. ANALYSIS DETERMINED THE PUMP PASSED FLOW TESTING WITHIN SPECIFICATIONS. DEFORMATION OBSERVED ON THE END OF THE DISPENSING TIP, THE OPENING WAS NOT COMPLETELY CLOSED. THIS DAMAGE DID NOT AFFECT THE DEVICE DISPENSING DURING BENCH TESTING. THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THE CATHETER WAS RECONNECTED TO THE NEW PUMP.

    Description of Event or Problem · 1

    VIA AN X-RAY (DATE NOT REPORTED), IT WAS DETERMINED THAT THE CATHETER WAS DISCONNECTED FROM THE PUMP. THE PATIENT DID NOT HAVE ANY SYMPTOMS AT THE TIME OF DISCOVERY. THE PATIENT CHOSE TO DISCONTINUE THERAPY FOR A TIME DUE TO THE DISCONNECT. ONCE THE PATIENT WANTED TO RESUME THERAPY, THE PATIENT WAS ALSO DUE FOR A PUMP REPLACEMENT FOR BATTERY LIFE EXCHANGE. THE PUMP WAS REPLACED AND THE CATHETER WAS RECONNECTED TO THE NEW PUMP. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL 8709| EXPLANTED: