BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153306 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00606
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) POWERED ON WITH A "SELF TEST" ERROR MESSAGE. ANOTHER EPG WAS USED. THE CALLER REPLACED THE BATTERY AND THE EPG POWERED UP TO DEFAULT SETTINGS WITHOUT ANY ERROR. THE CALLER DID THIS SEVERAL MORE TIMES AND EACH TIME IT POWERED UP NORMALLY. TECHNICAL SERVICES EXPLAINED HOW THE ERROR COULD OCCUR, AND HOW TO CLEAR IT. THE EPG WILL BE PLACED BACK INTO SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256135 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1