BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153449 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01434
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 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. CONCOMITANT PRODUCTS: PRODUCT ID 2067L RF HEAD; PRODUCT ID 229047 ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER HAD A OVERHEATED MESSAGE DUE TO THE POWER SUPPLY FAN NOT WORKING, AS A RESULT THE POWER SUPPLY WAS REPLACED. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS NOISY.

    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 WAS OVERHEATING. THE COMPANY REPRESENTATIVE WAS ABLE TO COMPLETE THE SESSION. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS OVERHEATING. THE COMPANY REPRESENTATIVE WAS ABLE TO COMPLETE THE SESSION. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256582 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1