BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2781059 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13227
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 26, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PROCEDURE WAS SCHEDULED AND THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE BATTERY STATUS WAS END OF LIFE (EOL) WITH A CHARGE TIME OF 30 SECONDS AND A BATTERY VOLTAGE OF 2.67V. A FOLLOW-UP TWO MONTHS PRIOR NOTED A BATTERY STATUS OF BEGINNING OF LIFE (BOL) WITH A CHARGE TIME OF 7.2 SECONDS AND A BATTERY VOLTAGE OF 3.04V. THE PATIENT WAS HOSPITALIZED AS A REPLACEMENT PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS DEVICE WAS EXPLANTED. 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 T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization