BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3951284 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13393
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP FOUND A SIGNIFICANT ANOMALY. DURING DESTRUCTIVE ANALYSIS A FOREIGN PIECE OF MATERIAL WAS FOUND ADHERED TO THE BOTTOM SIDE OF THE INNER COVER. THE COLOR AND SHAPE OF THIS PIECE OF MATERIAL WAS CONSISTENT WITH THE WIRE INSULATION USED ON THE TOP SIDE MOTOR WIRES. THE MATERIAL WAS HOLLOW AND APPEARED TO HAVE BEEN MELTED ON ONE SIDE TO THE BOTTOM SIDE OF THE INNER COVER. THE MATERIAL WAS PRESERVED BETWEEN GLASS SLIDES AND LOCATED WITH THE PUMP IN THE CHANCE ANY FURTHER ANALYSIS IS NEEDED OR WANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2014 AS IT WAS SEVEN YEARS OLD AND WAS REPLACED BEFORE END OF LIFE. IT WAS NOTED TO HAVE BEEN PROPHYLACTIC REMOVAL TO AVOID IN-VIVO BATTERY DEPLETION. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELAE AND THERE WAS NO PATIENT INJURY. NO DYE OR ROTOR STUDY WAS PERFORMED. THE PATIENT'S PUMP WAS INTENDED TO INFUSE INTRATHECAL LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428523 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1