BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 3210835 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07168
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE AND THEREFORE WILL NOT BE RETURNED FOR ANALYSIS TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THIS EVENT. 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 WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPAL EPISODE AND REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) AND WAS SUBSEQUENTLY HOSPITALIZED. THE DEVICE WAS INTERROGATED AND REVEALED RHYTHM ACCELERATION OCCURRED. VENTRICULAR TACHYCARDIA (VT) WAS INITIALLY DETECTED FROM THE DEVICE AT A RATE OF 216 BEATS PER MINUTE WHICH FELL INTO THE DEVICES MONITOR ONLY ZONE. THE VENTRICULAR TACHYCARDIA (VT) WAS SUSTAINED IN THE MONITOR ONLY ZONE FOR UP TO EIGHT MINUTES AND FURTHER ACCELERATED INTO VENTRICULAR FIBRILLATION (VF). A SHOCK WAS DELIVERED AND SUCCESSFULLY CONVERTED THE PATIENT TO A NORMAL SINUS RHYTHM. THE DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309138 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L 5076| H199| 4087| 0165| F030