BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3053152 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04501
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    October 21, 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

    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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THIS DEVICE WAS EXPLANTED WITH NO FURTHER FOLLOW UPS. THE DEVICE HAD NOT TRIGGERED ERI. THE DEVICE WILL BE RETURNED FOR ANALYSIS. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP IT WAS NOTED THAT THE DEVICE WAS AT MIDDLE OF LIFE (MOL2) AFTER BEING IMPLANT FOR THREE YEAR AND 10 MONTHS. AS THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI), IT WAS SUSPECTED THAT THE DEVICE WAS NOT GOING OT LAST THE PROJECTED AMOUNT OF LONGEVITY. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE REMAINS IMPLANTED. IT WAS NOTED THAT A REPLACEMENT WILL TAKE PLACE WHEN THE DEVICE REACHES ERI NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155223 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R