BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 1041100 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-35009
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 1, 2007
    Report Date
    June 17, 2010
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANALYSIS IS ONGOING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PATIENT HAS REQUESTED A RESPONSE FROM THE COMPANY REGARDING THEIR DEVICE AND/OR SERVICES. ADDITIONALLY, THIS DEVICE WAS APART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY COMMUNICATED ON (B) (6) 2007 AS IT DISPLAYED A BATTERY VOLTAGE OF 2.6 VOLTS WITHIN 27 MONTHS OF IMPLANT. ADVISORY RECOMMENDATIONS WERE TO INTENSIFY FOLLOW-UPS TO MONTHLY. THE LOCAL FIELD REPRESENTATIVE WAS TO DISCUSS ADVISORY WITH THE PATIENT'S PHYSICIAN. NEW INFORMATION RECEIVED INDICATES THAT A REPRESENTATIVE FOR THIS PATIENT HAS RETAINED AN ATTORNEY AND RECENTLY SUBMITTED PAPERWORK AS PART OF THE LITIGATION PROCESS. BOSTON SCIENTIFIC HAS NO SPECIFIC INFORMATION AS TO WHETHER THERE WERE ANY ADVERSE PATIENT EFFECTS. RECENTLY THE PATIENT HAS COMPLAINED OF FEELING LIGHTHEADED AND RECEIVED INAPPROPRIATE SHOCKS DUE TO ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR