BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2171441 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09801
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    October 20, 2010
    Report Date
    June 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT ALL TESTING REVEALED SOLID NUMBERS, UNTIL THE AUTOCAPTURE TESTING WAS DONE ON THIS PACEMAKER DEPENDANT PATIENT. THE AUTOCAPTURE TEST RAN AND NEVER DID COMPLETE CAPTURE OR RECOGNIZE EVOKED RESPONSE. THE TEST WAS RAN AGAIN WITH THE SAME RESULTS. THE PATIENT WAS ASYMPTOMATIC. IT IS BELIEVED THAT THE AUTOCAPTURE IS NOT WORKING WITH THE NON BOSTON SCIENTIFIC LEAD. AS A RESULT AUTOCAPTURE WAS NOT USED WITH THIS PATIENT. THE PATIENT LATER CAME IN FOR A FOLLOW UP VISIT WITH LOSS OF CAPTURE ON THE NON BOSTON SCIENTIFIC LEAD. THIS LEAD ALSO EXHIBITED RISING THRESHOLDS. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONSULTED AND SUGGESTED THIS WAS MOST LIKELY A LEAD ISSUE, AND TO GET A CHEST X-RAY DONE TO CONFIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1