BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1080252 · Received July 22, 2008

    Report

    Report Number
    6000030-2008-04231
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    April 16, 2008
    Report Date
    July 15, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE PUMP REVEALED A RELIABILITY NON-CONFORMANCE - BOTH COIL MOUNTING SCREWS WERE BROKEN OFF.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO THE MANUFACTURER WHEN IT WAS REPLACED. THE RETURN PAPERWORK INDICATED THE DEVICE WAS REPLACED FOLLOWING NORMAL BATTERY DEPLETION; DEVICE RETURNED FOR DISPOSAL ONLY. THE RETURN PAPERWORK DID NOT SUGGEST OR QUESTION A MALFUNCTION AND NO PATIENT SYMPTOMS WERE REPORTED. THE PAPERWORK INDICATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER MORPHINE SULFATE. THE PUMP UNDERWENT ROUTINE ANALYSIS.

    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 EXPLANTED| PROGRAMMER MODEL PROGRAMMER| CATHETER MODEL 8703W