BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 SR

    MDR report key: 2810650 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05917
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 6, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON REMOTE TRANSMISSION THERE WAS A LOSS OF TELEMETRY WITH THE PACEMAKER ON THE MAGNET AND NON-MAGNET STRIPS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR901

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 5034 IMPLANTABLE PACING LEAD