BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3053562 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05285
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 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

    TO DATE, THE DEVICE REMAINS IMPLANTED. AT THIS TIME, NO ADDITIONAL INFORMATION WAS RECEIVED OF THE POTENTIAL REVISION PROCEDURE. DUE TO NO RETURN OF THIS DEVICE A ROOT CAUSE CAN NOT BE DETERMINED BY ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IMPLANTED. A FINAL REPORT WILL BE SENT AFTER INFORMATION IS RECEIVED OF THE REVISION PROCEDURE. IF THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED OUT OF RANGE CHARGE TIME OF 27 SECONDS WITH A BATTERY VOLTAGE OF 2.67 V. PREMATURE BATTERY DEPLETION (PBD) WAS SUSPECTED AS THE DEVICE DECLARED ERI 66 MONTHS POST IMPLANT. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP VISIT AND A REVISION PROCEDURE IN THE NEAR FUTURE. THE DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154970 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0181| T177