BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2041623 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00963
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, THE RV SETSCREW WAS RESEATED. FOLLOWING THE REVISION, NO FURTHER PATIENT EFFECTS WERE REPORTED, AND THE SYSTEM WAS OPERATING NORMALLY. INQUIRIES HAVE BEEN MADE BY THE CRIMINAL INVESTIGATION DEPARTMENT OF THE POLICE CONCERNING THE IMPLANTING PHYSICIAN. THE AVAILABLE INFORMATION SUGGESTS THE DEVICE REMAINS IMPLANTED WITH NO FURTHER COMPLICATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER HAD TWICE EXPERIENCED SYNCOPE AND COLLAPSED IN THE WEEKS AFTER IMPLANT. DURING A SCHEDULED FOLLOW-UP APPOINTMENT, NO OUT OF RANGE MEASUREMENTS WERE NOTED. THE PATIENT EXPERIENCED SYNCOPE AGAIN AND CHANGED PHYSICIANS. A LONG TERM EKG WAS PERFORMED, AND EPISODES OF COMPLETE HEART BLOCK WITH ESCAPE RHYTHMS LESS THAN 30 BPM WERE OBSERVED. IT WAS SUSPECTED THE RIGHT VENTRICULAR (RV) SETSCREW HAD NOT BEEN PROPERLY SEATED AT IMPLANT. THIS DEVICE IS NOT INCLUDED IN AN ADVISORY POPULATION.

    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 Life Threatening| R