BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 359435 · Received October 26, 2001

    Report

    Report Number
    359435
    Event Type
    Injury
    Date Received
    October 26, 2001
    Date of Event
    August 30, 2001
    Report Date
    October 4, 2001
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ICD CLINIC CHECK. OVERSENSING WAS DEMONSTRATED, UNRELATED TO THE EKG. NUMEROUS EPISODES OF NON-SUSTAINED TACHYCARDIA WERE RECORDED THAT WERE MOSTLY LIKELY DUE TO OVERSENSING EXAM BY DR. PT REPORTED FEELING WELL. DENIED ICD STOCKS, PALPITATIONS, CHEST DISCOMFORT. C/O SOME FATIGUES. NO PND, ORTHOPNEA OR EDEMA. S/P REPLACEMENT OF ICD WITH MEDTRONIC JEWELL ICD WITH BIPOLAR STOCKS. KUB X-RAY DEMONSTRATED DISCONTINUITY BETWEEN HEADER AND ONE LEAD PARTIALLY OUT OF CONNECTOR, INDICATING POSSIBLE MAKE/BRAKE CONNECTION AT THIS POINT WITH LUCENT SCREW. REMOVAL OF OLD ICD AND 2 LEADS. IMPLANTATION OF AICD WITH LEAD SYSTEM. DELAY O/T ANTICOAGULATION REVERSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48389 MEDTRONIC ICD LEAD LWS MEDTRONIC 6936 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization