BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIENT

    MDR report key: 1954000 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24121
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATOR HAD TROUBLE ESTABLISHING RADIO FREQUENCY (RF) TELEMETRY. THIS FEATURE WAS DISABLED ON THE PROGRAMMER, BUT ONCE ENABLED, INTERROGATION WAS SUCCESSFUL. IT WAS ALSO REPORTED THAT TACHYCARDIA THERAPY WAS EXHAUSTED. THE RHYTHM WOULD CONVERTED FOR SEVERAL SECONDS AFTER EACH THERAPY DELIVERY, BUT THEN THE RHYTHM WOULD RESUME LEADING TO MULTIPLE SHOCKS. IT WAS REPORTED THIS DEVICE WAS FUNCTIONING APPROPRIATELY. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED WHOM DISCUSSED POST SHOCK DURATION. CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1861| E030| 4472| 4469| 0154