BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 DR

    MDR report key: 1791111 · Received August 10, 2010

    Report

    Report Number
    2647346-2010-00355
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    March 30, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY: (B)(4) ANALYSIS REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN LOOKING AT THE EGM IT LOOKED LIKE THERE WAS ATRIAL FIBRILLATION OR NOISE; THE PATIENT WAS PRONE TO ATRIAL FIBRILLATION. IT WAS ALSO REPORTED THERE WAS CONCERN ABOUT THE DUAL EGM. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD 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 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 4024 IMPLANTABLE PACING LEAD