BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2952841 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00249
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 20, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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 STYLUS PEN ON THE PROGRAMMER WAS NOT WORKING. THE PEN WAS REPLACED BUT IT WAS STILL NOT WORKING. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO INDICATION OF ANY PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55920 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1