BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152480 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01549
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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 HEAD GOT NO TELEMETRY, AND THAT IT FAILED ALL UPLINK AMPLITUDE TESTS. THE HEAD'S CABLE WAS REPLACED AND THEN THE HEAD PASSED ALL FINAL ELECTRICAL TESTS AS WELL AS A BENCH SYSTEMS TEST. (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO TELEMETRY WITH THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD. THE RF HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO TELEMETRY WITH THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD. THE RF HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252855 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER