BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2911415 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16222
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 26, 2012
    Report Date
    April 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. 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 TOOL MARKS ON THE HEADER AND BODY FLUID CONTAMINATION IN THE LEAD BARRELS. ALL SEAL PLUGS WERE OBSERVED TO BE INTACT AND ALL SET SCREWS OPERATED APPROPRIATELY. THE INTERROGATED MONITORING VOLTAGE WAS 2.26 VOLTS AND THE BATTERY STATUS WAS END OF LIFE (EOL), EOL WAS SET BEFORE EXPLANT. A REVIEW OF STORED DEVICE MEMORY NOTED NO RESETS OR FAULT CODES. FURTHER REVIEW REVEALED 117 EPISODES WITH MULTIPLE ATTEMPTS THAT OCCURRED. THE DEVICE DECLARED EOL DURING THESE EPISODES DUE TO CHARGE TIMEOUT. REVIEW OF THE CUMULATIVE CHARGE TIME INDICATED THAT THE CELL DEPLETED NORMALLY. ANALYSIS CONCLUDED THAT EOL WAS REACHED BEFORE ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO AN EXTREME NUMBER OF HIGH VOLTAGE CHARGES IN ONE DAY. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL APPROPRIATE SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). INTERROGATION OF THE DEVICE REVEALED THAT A CHARGE TIME OUT FAULT HAD OCCURRED AND THAT THE DEVICE HAD REACHED END OF LIFE (EOL) FOLLOWING THE LAST DELIVERED SHOCK. ADDITIONALLY, DURING DEVICE INTERROGATION, THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT DECOMPENSATED INTO VF. THE DEVICE WAS CHARGING FOR OVER ONE MINUTE AND THE PATIENT EXPERIENCED ASYSTOLE AND REQUIRED EXTERNAL DEFIBRILLATION. THE PATIENT WAS UNCONSCIOUS AND HAD BEEN INTUBATED. THE LOCAL FIELD REPRESENTATIVE REPORTED THAT THE PATIENT'S FOLLOW UP HISTORY WAS UNKNOWN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THERAPY CANNOT BE GUARANTEED. DEVICE REPLACEMENT WILL BE SCHEDULED AFTER THE PATIENT STABILIZES.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17570 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R T135| 0185| 1194| 4087