BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2955279 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00257
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DEVICE WOULD NOT POWER ON. AFTER TROUBLESHOOTING WAS PERFORMED THE CAUSE WAS DETERMINED TO BE THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD OUT OF SPECIFICATION. PRODUCT ID 2067 RADIOFREQUENCY HEAD; PRODUCT ID (B)(4) ANALYZER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANTABLE CARDIODEFIBRILLATOR IMPLANT PROCEDURE THE PROGRAMMER SHUT DOWN AND DID NOT TURN ON. THE ELECTRICAL CORD WAS CHANGED OUT FOR A KNOWN GOOD ONE AND VARIOUS ELECTRICAL OUTLETS WERE TRIED BUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. FOLLOW-UP DETERMINED THAT THERE WAS ANOTHER PROGRAMMER READILY AVAILABLE AND THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59587 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1