BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2910016 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15142
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    April 1, 2013
    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

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    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.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGE TIME MEASUREMENTS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17757 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 0185| T177