BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3101859 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01559
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP FOUND HIGH RESISTANCE WITHIN THE PUMP BATTERY.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO RETURN PAPERWORK AND NO INFORMATION. THE PUMP UNDERWENT ROUTINE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203281 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1