BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 607793 · Received October 12, 2004

    Report

    Report Number
    607793
    Event Type
    Injury
    Date Received
    October 12, 2004
    Date of Event
    October 5, 2004
    Report Date
    October 12, 2004
    Manufacturer
    MEDTRONIC, INC.
    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

    DUAL CHAMBER ICD IMPLANTED IN 2001. 10/2004 PT BEGAN HAVING ICD SHOCKS, THAT BECAME FREQ. SAME DAY WITH TOTAL OF 10 ICD SHOCKS. VENTRICULAR LEAD FAILURE WAS DETERMINED. THE PT WAS ADMITTED TO HOSP ON SAME DAY HOWEVER DUE TO BEING ON ASPIRIN AND PLAVIX FOR CARDIOMYOPATHY, SURGERY WAS DELAYED FOR 5 DAYS. IN 10/2004 THE PT UNDERWENT REMOVAL AND RE-IMPLANTATION OF VENTRICULAR LEAD AND ICD GENERATOR. ICD INTEROGATION SHOWED HIGH VENTRICULAR LEAD IMPEDANCE. ALL SHOCKS DURING SINUS RHYTHM AND DUE TO OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULAR ICD LEAD LWS MEDTRONIC, INC. 6977-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization