BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153036 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01386
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IT WAS ALSO NOTED THAT THE LABEL BACKING WAS MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A BROKEN LID AND THAT IT WAS "SHORTING." 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
    256144 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1