BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 1946247 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20447
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ERI AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE ERI CHARGE TIME LIMIT OF 18 SECONDS. THE DEVICE PASSED A SERIES OF DIAGNOSTIC TESTS TO ASSESS THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING, AND DIAGNOSTIC RECORDING FUNCTIONS. THE DEVICE'S MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. CHARGE TIMES IN EXCESS OF THE 18 SECOND ERI CHARGE TIME LIMIT TRIGGERED ERI EARLIER THAN EXPECTED. THIS WAS DUE TO A BUILD-UP OF INTERNAL BATTERY IMPEDANCE, PREVENTING THE DEVICE FROM MEETING ITS EXPECTED LONGEVITY PER DEVICE LABELING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S SYMPTOMS WERE UNRELATED TO THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING BEEP TONES. THE PATIENT INDICATED THAT THEY HAD NOT BEEN FEELING WELL. THE PATIENT WAS INSTRUCTED TO CONTACT THEIR PHYSICIAN REGARDING THIS. IT WAS REPORTED THAT THE DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). THE FIELD REPRESENTATIVE INDICATED THAT THE DEVICE LASTED ONLY 3.5 YEARS. TECHNICAL SERVICES (TS) INQUIRED IF THERE WERE ANY ALLEGATIONS AGAINST PREMATURE BATTERY DEPLETION AND THE FIELD REPRESENTATIVE INDICATED NO, NO PREMATURE BATTERY DEPLETION ALLEGATIONS HAVE BEEN REPORTED. 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 66 YR 1852| 0181