BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1182293 · Received September 17, 2008

    Report

    Report Number
    1182293
    Date Received
    September 17, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS TWO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS. ADMITTED FOR EVALUATION OF POSSIBLE WORSENING OF HIS CORONARY ARTERY DISEASE TO INCLUDE LEFT HEART CATHETERIZATION AND A GENERATOR CHANGE OF HIS BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ICD LWS BOSTON SCIENTIFIC H177 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR