BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2171238 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09872
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE, WHICH WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2007, DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH AN EXTENDED CHARGE TIME MEASUREMENT OF 21 SECONDS AND A MONITORING VOLTAGE OF 2.56 VOLTS. A REPLACEMENT PROCEDURE WAS PLANNED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND RETURNED FOR RELIABILTIY ANALYSIS.

    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 59 YR T165| 4472| 0157