BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2171609 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10647
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    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

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ERI. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISPLAYED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). THE MONITORING VOLTAGE WAS 2.68 AND THE CHARGE TIME WAS 19.2 SECONDS. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    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 80 YR Hospitalization| L| R T175| 0184