BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1951988 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23229
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS WITH A MONITORING VOLTAGE OF 2.5 V. TO DETERMINE IF THE BATTERY DEPLETED IN A NORMAL FASHION, OUR LABORATORY TECHNICIANS USED ENGINEERING FORMULAS TO CALCULATE EXPECTED LONGEVITY. BASED ON THE AVAILABLE PARAMETERS AND THERAPY HISTORY, WE DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY. DESPITE EXHAUSTIVE ANALYSIS, WE WERE UNABLE TO ASCERTAIN THE ROOT CAUSE OF THE PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS AND WAS REPLACED WITH ANOTHER ICD. UPON RECEIPT, INITIAL LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY PREDICTIONS AS DESCRIBED IN DEVICE LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 1860| E102| 1782| 1742| 0125