BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2163537 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07445
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, 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 THIS PATIENT IMPLANTED WITH THIS PACEMAKER WAS FEELING NAUSEOUS AND WEAK AND PRESENTED TO THE HOSPITAL VIA AMBULANCE. THE PATIENT'S HEART RATE APPEARED TO HAVE PAUSES AND RATES AROUND THE 20 BPM RANGE WHILE BEING TRANSPORTED. A LOCAL SALES REPRESENTATIVE WAS PAGED TO CHECK THE DEVICE AND ALL FUNCTIONS AND LEAD MEASUREMENTS WERE NORMAL. THE SALES REPRESENTATIVE NOTED THE PATIENT HAD AUTO CAPTURE PROGRAMMED ON AND PACING AT AUTO 3.5V WITH THRESHOLDS AROUND .9V. WHEN THE DEVICE WAS CHECKED, THE OUTPUTS CHANGED TO 1.4V. THE PHYSICIAN WAS CONCERNED THERE MAY HAVE BEEN A LOSS OF CAPTURE ISSUE. THE SALES REPRESENTATIVE NOTED THE PATIENT HAD A NORMAL INTRINSIC WHEN SHE CHECKED THE DEVICE, HOWEVER PER THE PHYSICIAN'S PREFERENCE, PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR 4135| 4136| S602