BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1850053 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-13971
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. 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, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE TIME (CT) OF 17.9 SECONDS AND MONITORING VOLTAGE OF 2.55, AND HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). WHEN THE PATIENT WAS BROUGHT IN FOR A DEVICE REPLACEMENT, IT WAS NOTED THAT THE DEVICE HAD PERFORMED AN AUTOMATIC CAPACITOR REFORMATION (ACR), RESULTING IN A CT OF 13.8 SECONDS AND BATTERY VOLTAGE OF 2.66. TECHNICAL SERVICES (TS) DISCUSSED THAT THIS WAS NORMAL DEVICE OPERATION TO PERFORM A SECOND ACR, BUT THAT THIS DEVICE COULD BE EXHIBITING A CT ANOMALY. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 4472| T167| 0185