BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200073 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-00985
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 25, 2007
    Report Date
    May 25, 2007
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED BECAUSE OF THE MAGNET BEING USED DURING TELEMETRY. THE LOGS HAD NOT YET BEEN CHECKED TO DETERMINE IF THE STALL RECOVERED. THERE WERE NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297975 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1