BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 6932690 · Received October 9, 2017

    Report

    Report Number
    2124215-2017-15174
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    February 15, 2017
    Report Date
    August 15, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS SYSTEM WAS PROGRAMMED OFF FOR AN ENDOSCOPY PROCEDURE. DURING THE PROCEDURE, THE RED RESCUE SHOCK ALERT PRESENTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONCLUDED THE HEALTH CARE PROFESSIONAL (HCP) LIKELY PRESSED THE RESCUE SHOCK BUTTON. TS ALSO INDICATED THAT EVEN THROUGH THE SCREEN APPEARED, ANOTHER BUTTON IS REQUIRED BEFORE THE SHOCK IS DELIVERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712881 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A209

    Patients

    Seq Age Sex Outcome Treatment
    1