BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1871132 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17382
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 30, 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 Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED AND IS UNDERGOING DETAILED LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS EARLIER THAN EXPECTED. IN (B)(6) 2009, THE MONITORING VOLTAGE WAS 2.99V AND THE CHARGE TIME WAS 6.9 SECONDS. TECHNICAL SERVICES DISCUSSED THAT ERI WAS TRIGGERED DUE TO CHARGE TIME. THE DEVICE WAS EXPLANTED AND WAS REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICD.

    Description of Event or Problem · 1

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    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 63 YR Required Intervention E110| T167| 0184| 4469