BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1980985 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02177
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS MEDICAL DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S ALLEGATION OF SYNCOPE. THIS PATIENT DID PRESENT TO THE EMERGENCY ROOM WITH SYMPTOMS OF DIZZINESS AND FEELING UNEASY PERIODICALLY. THE MEDICAL PERSONNEL WHO EVALUATED HER AT THIS TIME INDICATED THAT THE PATIENT HAS THESE SYMPTOMS WITH V-PACING. THE PATIENT WAS NOTED AS NOT V-PACING MUCH, AS SHE WAS IMPLANTED FOR SINUS BRADY, BUT IT WAS OBSERVED THAT THERE IS SOME ATRIAL TACHYCARDIA THAT OCCURS DURING MODE SWITCHES AND THIS IS WHEN THE PATIENT EXPERIENCES THE SYMPTOMS DESCRIBED. THE MEDICAL PERSONNEL WAS ABLE TO REPRODUCE THE ISSUE IN DDD AND VVI MODES, AND THE OUTCOMES WERE THE SAME WHETHER WITH HIGH OUTPUT, LOW OUTPUT, UNIPOLAR, BIPOLAR, ETC. ALL LEAD MEASUREMENTS WERE NOTED WITHIN NORMAL LIMITS. A CHEST X-RAY WAS DONE THAT DID NOT REVEAL ANY PERFORATION. A NICE APICAL POSITION OF THE LEAD WAS NOTED. THERE WAS NO MUSCLE STIMULATION AT ANY OUTPUT. THERE WAS SOME DISCUSSION REGARDING THE TOPIC OF PSEUDO-PACEMAKER SYNDROME, WHICH IS WHEN SOME PATIENTS CAN TELL THE DIFFERENCE BETWEEN CONDUCTED R-WAVES AND PACED R-WAVES. THIS DEVICE PERFORMED WITHIN NORMAL LIMITS ON ALL ACCOUNTS, HOWEVER THERE WAS NEVER DIRECT CONFIRMATION THAT THE ALLEGATION OF SYNCOPE WAS NOT POSSIBLY RELATED TO DEVICE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4470| 4469| S603