BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 6482590 · Received April 11, 2017

    Report

    Report Number
    2124215-2017-05237
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 9, 2017
    Report Date
    March 21, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    UDI-DI
    00802526544101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 FIELD CLINICAL MANAGER(FCM) CONTACTED BOSTON SCIENTIFIC¿S TECHNICAL SERVICES (TS). THE FCM REPORTED THAT INTERROGATION OF THIS DEVICE WAS TAKING A LONG TIME. TS COMMENTED THAT REBOOTING OF THE PROGRAMMER TENDS TO RESOLVE THIS ISSUE. THE FCM WAS PLANNING TO CALL BACK IF DEVICE INTERROGATION WAS UNSUCCESSFUL. TO DATE, NO ADDITIONAL CALLS FROM THE FCM CONCERNING THIS ISSUE HAVE BEEN RECEIVED. THE AVAILABLE INFORMATION SUGGESTS THAT DEVICE INTERROGATION WAS SUCCESSFUL AND THE DEVICE REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261261 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A209 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 3400| A209