BEUDAMED
    FDA Adverse Event Death Summary report: N

    S-ICD SYSTEM

    MDR report key: 6200207 · Received December 22, 2016

    Report

    Report Number
    2124215-2016-21501
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    December 6, 2016
    Report Date
    December 9, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THE DEVICE REMAINED IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXPIRED THE DAY AFTER IMPLANT. THE CAUSE OF DEATH WAS BELIEVED TO BE PULMONARY EDEMA. THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850297 S-ICD SYSTEM LWS GUIDANT CRM CLONMEL IRELAND A219

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death (B)(4)| (B)(4)