BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153387 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01419
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 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 WAS UNABLE TO CONFIRM THE REPORTED EVENT. THE DEVICE WAS ABLE TO INTERROGATE AN IMPLANTABLE CARDIAC DEVICE AND TELEMETRY REMAINED CONSTANT EVEN AS THE CABLE WAS MOVED BACK AND FORTH FROM END OF THE CABLE TO THE OTHER. IT WAS NOTED THAT THE CABLE WAS FRAYED AND VERY TWISTED, THE RUBBER PORTION OF THE HEAD LABEL WAS GONE AND THE LENS WAS CRACKED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WOULD NOT COMMUNICATE WITH DEVICES, AND THE WIRE WAS FRAYED. THE RF HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258902 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER