BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990122 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02264
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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 WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT TURN ON HOWEVER THE POWER SUPPLY WAS REPLACED AS A PREVENTIVE. ANALYSIS DID CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT UPDATE SOFTWARE, AT LEAST VIA THE SOFTWARE DISTRIBUTION NETWORK AND THEREFORE THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. IT WAS FURTHER NOTED THAT A FLOPPY DISK SPRING WAS FOUND IN THE FLOPPY DRIVE AND THE FLOPPY DRIVE WAS REPLACED AS A PREVENTIVE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (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 TURN ON AND WOULD NOT UPDATE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4)-IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT TURN ON AND WOULD NOT UPDATE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462494 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

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