BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3113498 · Received May 15, 2013

    Report

    Report Number
    3007566237-2013-01618
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PUMP REVEALED BATTERY HIGH RESISTANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO ERI. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214732 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR