BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200014 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-00968
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    March 16, 2005
    Report Date
    March 16, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MOTOR STALL. THE MOTOR STALL OCCURRED DUE TO A MAGNET BEING USED DURING PROGRAMMING. THE MOTOR STALL RECOVERED WITHIN FIVE MINUTES AND THE PUMP WAS SUCCESSFULLY PROGRAMMED. THERE WERE NO PATIENT SYMPTOMS REPORTED ALONG WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297926 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1