BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SEM III ICD SYSTEM

    MDR report key: 401069 · Received June 20, 2002

    Report

    Report Number
    401069
    Event Type
    Injury
    Date Received
    June 20, 2002
    Date of Event
    February 27, 2002
    Report Date
    May 13, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR LEAD FRACTURE IN ICD SYSTEM THAT RESULTED IN INAPPROPRIATE ICD SHOCKS. LEAD WAS SURGICALLY REMOVED AND REPLACED. PT HOSPITALIZED FOR DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SEM III ICD SYSTEM ICD-(DEFIBRILLATOR) (LEAD FAILURE) LWS MEDTRONIC, INC. 6943 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R