BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2953591 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00186
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE FAILED TELEMETRY TESTING DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 5 LEAD CABLE ON THE PROGRAMMER WAS COMING ACROSS VERY DIRTY, AND THAT NEW ELECTRODES WERE TRIED AND THAT EACH LEAD WAS "PLAYED WITH" BUT THAT A CLEAN SIGNAL COULD NOT BE ACHIEVED AT ALL. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57635 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MILACA, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1