BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153343 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01417
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; RF (RADIO FREQUENCY) HEAD FAILED TWO UPLINK AMPLITUDE TESTS. RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE RUBBER PORTION OF THE RF HEAD LABEL IS MISSING.

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RF (RADIO FREQUENCY) HEAD MALFUNCTIONED FROM STERILE PROCESSING AND PACER CLINIC. NO ADDITIONAL INFORMATION WASOBTAINED THROUGH FOLLOW UP. THE RF HEAD WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258096 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1