BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151648 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01307
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 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

    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE PROGRAMMER POWERED DOWN AFTER A FEW MINUTES OF RUNNING. AS A RESULT THE POWER SUPPLY WAS REPLACED TO RESOLVE THE POWERING ISSUE. IT WAS ALSO NOTED THAT THE OVERLAY WAS CRACKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD INTERMITTENTLY SHUT OFF WHILE BEING POWERED ON, AND IT POWERED DOWN DURING INTERROGATIONS. THE POWER CORD WAS REPLACED AND THE SERVICE DISK ATTEMPTED, BUT THE ISSUE WAS NOT RESOLVED. A POWER SUPPLY ISSUE WAS SUSPECTED. THE PROGRAMMER 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
    253155 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD