BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200017 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-01095
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 10, 2005
    Report Date
    May 10, 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

    A PROBLEM WAS REPORTED RELATED TO PUMP. A MOTOR STALL WAS REPORTED AFTER ATTEMPTING TO READ THE PUMP WITH A MAGNET. COMPANY REPRESENTATIVE REPORTED HCP INCORRECTLY USED MAGNET WITH A SYNCHROMED II PUMP. NO PATIENT SYMPTOMS OR OUTCOME WERE REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297927 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1