BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 1041556 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31973
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    August 13, 2007
    Report Date
    May 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS CURRENTLY ON LEGAL HOLD DUE TO PENDING LITIGATION AND CANNOT BE ANALYZED BY THE POST MARKET QUALITY ASSURANCE LABORATORY. IF LEGAL CLEARANCE IS RECEIVED THE DEVICE WILL BE ANALYZED AND THE EVENT UPDATED. THIS DEVICE IS INCLUDED IN THE FOLLOWING ADVISORY POPULATIONS: AVT LATCHING POPULATION COMMUNICATED ON (B)(6) 2005 AND THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS COMMUNICATED ON (B)(6) 2007. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. INITIAL ANALYSIS NOTED THAT THE DEVICE DID NOT HAVE TELEMETRY FUNCTION AND A BUZZING SOUND FROM THE DEVICE WAS OBSERVED DURING HANDLING. THE DEVICE CASE WAS REMOVED AND INTERNAL VISUAL INSPECTION REVEALED THAT A COMPONENT WITHIN THE ACCELEROMETER WAS DAMAGED. THE DAMAGE WAS SUSPECTED TO BE A RESULT OF CHEST TRAUMA THE PATIENT SUSTAINED FROM A MOTOR VEHICLE ACCIDENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH IS INCLUDED IN THIS ADVISORY POPULATION RETAINED LEGAL COUNSEL AND PLANS TO FILE A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST DEVICE MALFUNCTION. NEW INFORMATION RECEIVED INDICATES THAT THIS PATIENT WAS IN A MOTOR VEHICLE ACCIDENT WITH TRAUMA TO THE CHEST AREA. THE DEVICE WAS NOT INTERROGATED PRIOR TO DISCHARGE. ONE MONTH LATER THE PATIENT PRESENTED WITH WHISTLING NOISE FROM DEVICE AREA. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention THE DEVICE 0185/101343 WAS IMPLANTED 13-MAY-2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2004| THE DEVICE 4086/150416 WAS IMPLANTED 13-MAY-2004