BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2171489 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11193
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 15, 2009
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO POCKET EROSION. THIS INFORMATION WAS REVEALED DURING A HOSPITAL THIRD PARTY AUDIT INWHICH THE PATIENT FILES WERE REVIEWED. FURTHER INVESTIGATION REVEALS THAT THE OUT OF SERVICE PAPERWORK SUBMITTED BY A BOSTON SCIENTIFIC SALES REPRESENTATIVE BACK IN 2009 INDICATED THAT THIS PRODUCT WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND NO ADVERSE PATIENT EFFECTS WERE REPORTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R 1861| 1853| T125| 4465| 4471| 0148| E110