BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 6020627 · Received October 12, 2016

    Report

    Report Number
    2124215-2016-12532
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 20, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 SIX DAYS POST IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM, AN UNTREATED EPISODE WAS STORED DUE TO NOISE. THE DEVICE WAS PROGRAMMED TO SECONDARY VECTOR WITH A 1X GAIN. THE NOISE APPEARED NON-PHYSIOLOGIC AND MAY BE RELATED TO THE SET SCREW CONNECTION TO SENSE A ELECTRODE. THE PHYSICIAN REPROGRAMMED THE TACHYCARDIA ZONES TO 210/250 IN PRIMARY SENSING VECTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673333 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A209

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 3401| A209