BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153346 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01411
    Event Type
    Malfunction
    Date Received
    June 8, 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. CONCOMITANT PRODUCTS: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: 2090: ANALYSIS DID NOT CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE, WHEN A KNOWN GOOD HEAD WAS USED THE PROGRAMMER WAS ABLE TO INTERROGATE WITH NO FAULT FOUND. THE PROGRAMMER PASSED ALL INCOMING, CONSOLE AND SYSTEMS TESTS. PRODUCT ID 2067L, RADIO FREQUECNY PROGRAMMER HEAD; (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 THAT THE PROGRAMMER WAS INTERMITTENTLY UNABLE TO INTERROGATE IMPLANTABLE HEART DEVICES. THE RADIO FREQUENCY PROGRAMMER HEAD WAS CHANGED OUT BUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS INTERMITTENTLY UNABLE TO INTERROGATE IMPLANTABLE HEART DEVICES. THE RADIO FREQUENCY PROGRAMMER HEAD WAS CHANGED OUT BUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258093 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1