BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2171267 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-12138
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 27, 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS DISCARDED BY HOSPITAL STAFF. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED BEEPING TONES. DEVICE INTERROGATION FOUND THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGE TIMES EXCEEDING THE EXTENDED CHARGE TIME LIMIT. AN INVASIVE PROCEDURE WAS PERFORMED. THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 0184| T175