BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1950464 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22420
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1513-08 TO Z-1514-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND DETAILED ANALYSIS IS PENDING.

    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.

    Additional Manufacturer Narrative · 1

    A RETURN REQUEST WAS MADE FOR THIS PRODUCT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DECLARED THE ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A CHARGE TIME OF 19.1 SECONDS. ON THE DAY OF EXPLANT, THE DEVICE THEN MEASURED 2.67 VOLTS WITH CHARGE TIMES OF 16.6 SECONDS. TECHNICAL SERVICES DISCUSSED DEVICE BEHAVIOR AND RECOMMENDED REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY.

    Description of Event or Problem · 1

    --

    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 80 YR Required Intervention 0158| T177