BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 2042275 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01204
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    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 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 DEFIBRILLATOR DISPLAYED ELECTIVE REPLACEMENT INDICATORS (ERI). A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED. INTERROGATION REVEALED THE DEVICE HAD VENTRICULAR PACED ONE PERCENT SINCE IMPLANT AND HAD DELIVERED TWELVE SHOCKS. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 38 YR Required Intervention