BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160956 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02775
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; THE PROGRAMMER BOOTED UP TO A SYSTEM ERROR. THE XY PRINTED CIRCUIT BOARD ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. SYSTEM FAN FOUND NOISY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER "LOCKED UP" AND WOULD NOT RESET AFTER A POWER CYCLE. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641066 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1