BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2151750 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06487
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 21, 2011
    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 HAS NOT BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED THE CASE WAS SWOLLEN AND THERE IS BODY FLUID CONTAMINATION IN THE LEAD BARRELS. THE DEVICE HAS NO TELEMETRY AND NO MAGNETIC TONES ARE EMITTED WHEN A MAGNET IS PLACED ON THE DEVICE. THE PULSE GENERATOR CASE WAS THEN REMOVED. INTERNAL VISUAL INSPECTION NOTED THE CELL WAS SWOLLEN. THIS IS NORMAL DUE TO THE CELL BEING DEPLETED. AN EXTERNAL POWER SOURCE WAS CONNECTED TO VERIFY THE INTERNAL CURRENT OF THE DEVICE. THE POWER SUPPLY VOLTAGE MEASUREMENTS WERE NORMAL. DURING ANALYSIS, ALL CURRENT MEASUREMENTS WERE WITHIN NORMAL LIMITS. MANUAL ELECTRICAL MEASUREMENTS NOTED NORMAL PACING, SENSING, AND DEFIBRILLATOR FUNCTIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TELEMETRY COULD NOT BE ESTABLISHED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOLLOWING A NON-DEVICE RELATED SURGERY. UPON MAGNET APPLICATION, TONES WERE NOT EMITTED FROM THE DEVICE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. WHEN THE DEVICE WAS REMOVED FROM THE POCKET IT WAS NOTED THAT THE CASE WAS DEFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention T165| 4480| 6949