BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 SR

    MDR report key: 2791120 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02192
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) - PERFORMANCE DATA WAS RECEIVED AND ANALYZED. THE SAVE TO DISK PRIMARY FINDING NOTED LONGEVITY AND BATTERY DATA DEPLETION EOL/EOS/ERI/RRT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE UNDERWENT AN ELECTRICAL RESET UPON INTERROGATION. THE DEVICE IS AT ELECTIVE REPLACEMENT INDICATOR (ERI). NO DATA IS AVAILABLE FOR BATTERY VOLTAGE/IMPEDANCE AND DIAGNOSTICS. THE DEVICE RESET WAS CLEARED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 SR PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC S.A. KSR701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 8940 IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD