BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2840880 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10593
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP FOUND MOTOR GEAR TRAIN ANOMALY. THE ANOMALY WAS CORROSION, AND OR WEAR AND OR LUBRICATION. DESTRUCTIVE ANALYSIS REVEALED ENOUGH RESIDUES ON THE UPPER SHAFT OF THE ROTOR TO CAUSE A MOMENTARY MOTOR STALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED AND RETURNED TO MANUFACTURER FOR QUALITY ANALYSIS. NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICE WAS USED TO DELIVER BACLOFEN (LIORESAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1