BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3053121 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04420
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 18, 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 ABANDONED LEAD WAS NOT RETURNED FOR ANALYSIS;THEREFORE THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. HOWEVER, THE EXPLANTED DEVICE WAS SENT BACK FOR ANALYSIS. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. AN EXTERNAL VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED VISUAL INSPECTION NOTED TOOL MARKS ON THE SWOLLEN CASE. THE CASE ON THE DEVICE WAS OPENED AND INTERNAL VISUAL INSPECTION REVEALED NO IRREGULARITIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE WAS FOUND TO HAVE NO TELEMETRY THAT WAS ESTABLISHED. IT WAS NOTED THAT RESISTANCE TESTING INDICATED THE DEVICE HAD OUTPUT BRIDGE DAMAGE. AN EXTERNAL POWER SOURCE WAS SET TO THE DEVICE AND CONNECTED TO THE CIRCUIT AND THE DEVICE REVEALED THAT IT WOULD NOT RESTART. PRODUCT ANALYSIS WAS ABLE TO CONFIRM A DEVICE MALFUNCTION AND CONCLUDE THAT THE CAUSE OF THE NO TELEMETRY CONDITION IS THE DEVICE WAS DELIVERING A SHOCK INTO A SHORTED LEAD. THE DEVICE WAS ARCHIVED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED VENTRICULAR TACHYCARDIA (VT) WITH A HEART-RATE OF 170 BEATS PER MINUTE (BPM). THE DEVICE WAS PROGRAMMED, BUT DURING RE-PROGRAMMING THE DEVICE SHOCKED THE PATIENT. THE DEVICE WAS CHECKED AND WAS UNABLE TO BE INTERROGATED; THEREFORE THE PHYSICIAN COULD NOT CONFIRM THE DEVICE WAS CAPABLE OF PERFORMING ITS ESSENTIAL FUNCTION AND ELECTED TO EXPLANT THE DEVICE. DURING THE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN INSULATION ISSUE OBSERVED AND A NEW LEAD WAS IMPLANTED. THE DEVICE WAS REMOVED AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154987 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R