BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3053111 · Received April 11, 2013

    Report

    Report Number
    3007566237-2013-01214
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP ANALYSIS SHOWED LOGS GATHERED AND INDICATED A NORMAL ERI OCCURRED DUE TO TIME PROGRESSION AND A MOTOR STALL AND A MOTOR STALL RECOVERY AFTER PUMP WAS EXPLANTED. INFUSION TESTING ALSO DISPLAYED AN 'ODD' GRAPH WITH OVER INFUSION. MOISTURE AND RESIDUE WAS FOUND. PUMP TUBE WAS NARROWED IN ONE AREA AND WAS DISCOLORED AND HARDENED WITH A LOSS OF ELASTICITY. A COMBINATION OF MECHANICAL AND CHEMICAL STRESSES MAY HAVE CONTRIBUTED TO THE CHANGE IN THE CROSS SECTION OF THE TUBE CAUSES THE OVER INFUSION.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED WITH THE ONLY INFORMATION STATING "FOR DISPOSAL ONLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156899 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1