BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992235 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02407
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WAS UNABLE TO AUTO-IDENTIFY DEVICES BUT THE PROGRAMMER DID FAIL FUNCTIONAL VXI TESTS WHICH DID RELATE TO THE CUSTOMER COMMENTS. THIS WAS ATTRIBUTED TO THE RADIOFREQUENCY (RF) HEAD CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) BOARD BEING LOOSE AS WELL AS COLD SOLDER JOINTS AND THE LEM BOARD WAS THEREFORE REPLACED AND CALIBRATED. ANALYSIS ALSO FOUND THAT THE RIGHT KEYBOARD HINGE WAS BROKEN AND THAT THE "FEET" ON THE LOWER CASE WERE MISSING, BOTH THE RIGHT KEYBOARD HINGE AND THE LOWER CASE WERE REPLACED TO RESOLVE.

    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

    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 WOULD NOT AUTO-IDENTIFY IMPLANTABLE HEART DEVICES, THAT IT COULD NOT INTERROGATE A DEVICE AT ALL. 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
    471789 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIOFREQUENCY PROGRAMMER HEAD