BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 2041551 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01079
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    November 3, 2010
    Report Date
    February 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE VENTAK PRIZM DR 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) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS REPLACED. PREMATURE BATTERY DEPLETION WAS ALLEGED. 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 1853

    Patients

    Seq Age Sex Outcome Treatment
    1