BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153594 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01449
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    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 HAD A LONG BOOT TIME AND THEN BOOTED TO AN ERROR, THEREFORE THE SOFTWARE WAS RECONFIGURED AND RELOADED. ANALYSIS ALSO FOUND A NOISY SYSTEM FAN AND POWER SUPPLY, AND BOTH WERE 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. CONCOMITANT PRODUCT: PRODUCT ID 2067 RADIO FREQUENCY 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 HAD A LONG START-UP TIME AND THEN BOOTED TO AN ERROR. THE SERVICE DISK WAS RUN BUT THE SITUATION DID NOT RESOLVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A LONG START-UP TIME AND THEN BOOTED TO AN ERROR. THE SERVICE DISK WAS RUN BUT THE SITUATION DID NOT RESOLVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259150 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1