BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1861025 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15090
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO INTERVENTION IS PLANNED AT THIS TIME. THE PATIENT WILL CONTINUE NORMAL FOLLOW UPS UNTIL THE ICD REACHES END OF LIFE (EOL), AT WHICH TIME THE PHYSICIAN WILL CONSIDER REPLACING OR REPOSITIONING THE RA LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A PATIENT FOLLOW UP, THIS RIGHT ATRIAL (RA) LEAD PRESENTED WITH AN INCREASE IN THE PACING THRESHOLD AND LOSS OF ATRIAL CAPTURE. THE PACING IMPEDANCE AND SENSING MEASUREMENTS HAD REMAINED STABLE. AN X-RAY WAS TAKEN AND IT APPEARS THAT THE LEAD MAY HAVE MICRODISLODGED DUE TO THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MIGRATING AND CAUSING TENSION ON THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 4054| 0125| T165| 0155| 1821| 0148| 4294| 1861