BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3052713 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04090
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 5, 2013
    Report Date
    October 3, 2014
    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

    AVAILABLE INFORMATION INDICATES THIS DEVICE REMAINS IMPLANTED WITHOUT FURTHER COMPLICATION. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED. AS OF TODAY, THE EXPLANTED DEVICE HAS NOT BEEN RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED SHOULD THE DEVICE BE RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE, THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, DEFIBRILLATION, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING TONES FROM THE DEVICE. THE DEVICE WAS INTERROGATED AT A DIFFERENT CLINIC, AND THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE LEARNED THAT THE DEVICE WAS CONFIRMED TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS WITH A MONITORING VOLTAGE OF 2.59V AND A CHARGE TIME OF 18.9 SECONDS. A TECHNICAL SERVICES CONSULTANT DISCUSSED THE DEVICE DECLARED ERI DUE TO CHARGE TIMES THAT EXCEEDED THE MIDDLE OF LIFE CHARGE TIME EXTENSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155464 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R T167| 4064| 1851| 0145