BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860586 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01470
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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 SCREEN WAS CRACKED BUT WAS UNABLE TO CONFIRM THE OVERHEATING OR THE MESSAGE THAT IT WAS LOSING COMMUNICATION WITH THE ANALYZER. THE DISPLAY OVERLAY WAS REPLACED AND CALIBRATED AND THE LOW VOLTAGE DIFFERENTIAL SIGNAL PRINTED CIRCUIT BOARD ASSEMBLY WAS RESEATED. ANALYSIS ALSO FOUND BROKEN KEYBOARD HINGES AND THAT THE KEYBOARD COVER WAS MISSING, BOTH WERE REPLACED ALONG WITH THE KEYBOARD. CONCOMITANT PRODUCT: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT ID: 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A CRACKED SCREEN AND THAT IT WAS OVERHEATING. IT WAS FURTHER REPORTED THAT THE ANALYZER CONNECTED TO THE PROGRAMMER GENERATED A MESSAGE "LOSS OF COMMUNICATION, RESTART OR END SESSION IF PROBLEM PERSISTS." BOTH THE PROGRAMMER AND THE ANALYZER WERE RETURNED FOR SERVICE. 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 CRACKED SCREEN AND THAT IT WAS OVERHEATING. IT WAS FURTHER REPORTED THAT THE ANALYZER CONNECTED TO THE PROGRAMMER GENERATED A MESSAGE "LOSS OF COMMUNICATION, RESTART OR END SESSION IF PROBLEM PERSISTS." BOTH THE PROGRAMMER AND THE ANALYZER WERE 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
    341754 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090AA4

    Patients

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