BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153618 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01454
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED AN OVERHEAT EVENT OCCURRED VIA EVENT LOG. SERVICE DEPARTMENT WAS UNABLE TO CONFIRM/RECREATE THE OVERHEAT EVENT. REPLACED NOISY SYSTEM FAN, REPLACED POWER SUPPLY FROM SALVAGE INVENTORY AS PREVENTATIVE. CHECKED VENTS AND CPU HEAT SINK PAD/HEAT SINK (CASE) CONTACT AND RELOADED SOFTWARE PER PRODUCT PERFORMANCE REVIEW. EXECUTED GET LOGS AND GET PATIENT INFO APPLICATIONS, FOR RETRIEVAL AND ARCHIVING OF DEVICE AND PATIENT INFORMATION. RECONFIGURED HARD DRIVE AND RELOADED SOFTWARE. DEVICE PASSES FINAL FUNCTIONAL AND SYSTEM TESTS. NO OTHER ANOMALIES WERE FOUND.

    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 THERE IS AN OVERHEATING ERROR MESSAGE. THE PROGRAMMER WAS RETURNED FOR EVALUATION AND REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254276 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1