BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151674 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01284
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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 FOUND THAT THE PROGRAMMER WAS ABLE TO INTERROGATE USING A KNOWN GOOD HEAD AND MOVING THE CONNECTION DID NOT MAKE ANY CHANGES, PROGRAMMER PASSED FUNCTIONAL TESTING.

    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 PRODUCT: PRODUCT ID 2067L RF 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 DISPITE CHANGING PROGRAMMING HEADS, THE PROGRAMMER HAS ON / OFF ISSUES DETECTING DEVICES. THE PROGRAMMER WAS RETURNED TO CHECK THE CONNECTION PORT ON THE PROGRAMMER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252508 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1