BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3211325 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07962
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 28, 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 EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDER GO DETAILED ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES, AND THE ERI TO EOL TIME PERIOD WAS SHORTENED, DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE DEVICE WAS REMOVED AND REPLACED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION (PBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309421 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R