BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 968275 · Received December 19, 2007

    Report

    Report Number
    6000030-2007-04526
    Event Type
    Malfunction
    Date Received
    December 19, 2007
    Date of Event
    October 11, 2007
    Report Date
    November 20, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS RESULTS REVEAL - MOTOR GEAR SHAFT WEAR.

    Description of Event or Problem · 1

    THE PUMP WAS REMOVED AND RETURNED TO THE MFR FOR ANALYSIS DUE TO THE ONGOING SAFETY ALERT. THE DRUGS USED IN THE PUMP ARE DILAUDID 1.3 MG/M AND CLONIDINE 660 MCG/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK| CATHETER MODEL CATHETER LOT# UNK| IMPLANTED| EXPLANTED| IMPLANTED