BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3241091 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12099
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 19, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP (B)(4) REVEALED A PUMP MOTOR FEED THRU ANOMALY INVOLVING SHORTING ACROSS THE INSULATOR. BRIDGING WAS FOUND ACROSS THE CERAMIC INSULATION OF BOTH M1¿S AND M2¿S FEED THRU. CORROSION WAS ALSO FOUND ON GEAR WHEEL 3 AS WELL AS SLIGHT RESIDUE ON THE PINIONS OF THE GEAR SHAFTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED ON (B)(6) 2013 DUE TO BATTERY DEPLETION. NO PATIENT SYMPTOMS WERE REPORTED; HOWEVER, IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA FOLLOWING THE REPLACEMENT. THE DEVICE SYSTEM DELIVERED GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340945 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR