BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUS PLUS II

    MDR report key: 1870890 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16970
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 12, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    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 TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS REVEALED THIS DEVICE HAD NOT REACHED REPLACEMENT INDICATORS. ANALYSIS DETERMINED THE DEVICE OPERATED NORMALLY. THREE RESETS WERE NOTED IN THE DEVICE MEMORY. ANALYSIS CONCLUDED THAT THE REASON FOR THE CHANGE IN BATTERY STATUS AND THE LONGEVITY REMAINING MAY HAVE BEEN A RESULT OF THE RESETS. ANALYSIS COULD NOT DETERMINE A REASON FOR THE RESETS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED LONGEVITY GREATER THAN FIVE YEARS REMAINING AND BATTERY STATUS OF GOOD. DURING THE PREVIOUS VISIT, THIS DEVICE HAD DISPLAYED LESS THAN ONE-HALF YEAR REMAINING LONGEVITY. THE PATIENT WAS HOSPITALIZED AS THERE WAS CONCERN THE DEVICE MALFUNCTIONED. WHEN THE DEVICE WAS INTERROGATED DURING THE HOSPITALIZATION, THE DEVICE DISPLAYED LONGEVITY LESS THAN FIVE YEARS REMAINING. A REPLACEMENT PROCEDURE WAS PERFORMED, THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUS PLUS II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1480

    Patients

    Seq Age Sex Outcome Treatment
    1