BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1863203 · Received October 9, 2010

    Report

    Report Number
    2647346-2010-00610
    Event Type
    Injury
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    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 A PACEMAKER'S LONGEVITY PROJECTION DECREASED FROM A 6-26 MONTH RANGE IN (B)(6) 2010 TO LESS THAN ONE MONTH AT A CLINIC VISIT IN (B)(6) 2010. IT WAS FURTHER REPORTED THAT THE PACEMAKER MINUTE VENTILLATION SENSOR DETECTED 8 HIGH COUNTS ON THE SAME DAY AS THE PATIENT COMPLAINED OF A SHOCKING SENSATION AT THE SITE OF THE PACEMAKER. THE PACING SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 400 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 5076 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD