BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151548 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01151
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RICE CREEK MFG
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. HOWEVER, IT WAS NOTED THAT THERE WAS A STRESS MARK AT THE POINT WHERE THE CABLE ENTERS THE BODY OF THE HEAD. AS A PREVENTATIVE MEASURE THE CABLE WAS REPLACED. IT WAS ALSO NOTED THAT THE RUBBER PORTION OF THE LABEL WAS MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RF (RADIO FREQUENCY) HEAD WON'T READ DEVICES. 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
    253097 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1