BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 DR

    MDR report key: 1861537 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04803
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY DETERMINING CAPTURE ON THE ATRIAL LEAD FOR ALL 3 BEATS OF THE THRESHOLD MARGIN TEST (TMT). IT WAS ALSO REPORTED THAT "DURING 85 AT PROGRAMMED AV DELAYS", P-WAVES ARE PROMINENT. THE DEVICE 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 69 YR Other COMPETITOR-2 IMPLANTABLE PACING LEAD| COMPETITOR-1 IMPLANTABLE PACING LEAD