BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 1863595 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15398
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL TESTING REVEALED THAT THIS DEVICE FAILED THE INDUCED SHOCK (DELIVERED ENERGY) TEST. THE DEVICE WAS STABILIZED AND AN INDUCED SHOCK WAS PERFORMED, WHICH RESULTED IN THE DEVICE DELIVERING A 30.34 JOULE SHOCK. THIS WAS OUT OF SPECIFICATION FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). LONGEVITY CALCULATIONS DETERMINED THAT THIS DEVICE DID NOT MEET THE EXPECTED LONGEVITY BASED ON PROGRAMMED PARAMETERS AND THERAPY HISTORY. THE VENTAK PRIZM VR HE ERI CAN BE TRIPPED EITHER BY VOLTAGE OR CHARGE TIME. ANALYSIS CONFIRMED THAT THE ERI TIMESTAMP WAS TRIPPED BY CHARGE TIME, RATHER THAN BATTERY VOLTAGE. LABORATORY TESTING ALSO REVEALED THAT THE BATTERY CELL IN THIS DEVICE HAD SUFFICIENT CAPACITY REMAINING, BUT HAD AN EXCESSIVE BUILD-UP OF INTERNAL IMPEDANCE THAT WAS HIGHER THAN ALLOWED FOR BY DESIGN. THIS RESULTED IN THE DEVICE'S INABILITY TO UTILIZE ALL AVAILABLE BATTERY CAPACITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALLEGED TO DEPLETE PREMATURELY. THIS DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1852

    Patients

    Seq Age Sex Outcome Treatment
    1