BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991785 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02099
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    KRG
    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 CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER DID NOT STAY POWERED ON, IT DID NOT POWER ON FOR ANALYSIS AND THE POWER SUPPLY WAS THEREFORE REPLACED. (B)(4).

    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 CLICK ON THEN IMMEDIATELY TURN OFF. IN THE CALL TO TECHNICAL SERVICES IT WAS STATED THAT THE PROGRAMMER WOULD FIRST COME ON, THEN THE FAN, AND THEN IT WOULD TURN OFF. TRIED CHANGING OUT THE POWER CORD AND ELECTRICAL OUTLET, TRIED ANOTHER ROOM AND MANIPULATING THE CONNECTION BUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD CLICK ON THEN IMMEDIATELY TURN OFF. IN THE CALL TO TECHNICAL SERVICES IT WAS STATED THAT THE PROGRAMMER WOULD FIRST COME ON, THEN THE FAN, AND THEN IT WOULD TURN OFF. TRIED CHANGING OUT THE POWER CORD AND ELECTRICAL OUTLET, TRIED ANOTHER ROOM AND MANIPULATING THE CONNECTION BUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467770 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090AA4

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD| 2067 RADIOFREQUENCY PROGRAMMER HEAD