BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2914277 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00682
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THIS PATIENT THAT HE EXPERIENCED A NEAR SYNCOPAL EPISODE DURING A DEVICE CHECK. THE PATIENT RECOVERED WELL FROM THIS EXPERIENCE AND HIS ENERGY LEVEL WAS GOOD. ONE WEEK LATER, DURING A DEVICE CHECK, THE PATIENT LOST CONSCIOUSNESS AND WAS ADMITTED TO THE HOSPITAL. SINCE THIS LATEST CHECK AND HOSPITALIZATION, THE PATIENT HAS FELT VERY WEAK AND STATES HIS PULSE IS HARDLY DETECTABLE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WHO WAS PRESENT DURING THE MOST RECENT DEVICE CHECK PROVIDED ADDITIONAL DETAILS REGARDING THE OBSERVATIONS. THE REPRESENTATIVE STATED THAT THE PATIENT WAS SEATED UPRIGHT IN A CHAIR FOR THE CHECK. THERE WAS NEVER A MAGNET APPLIED TO THE DEVICE AND THE PATIENT WAS MOST LIKELY REFERRING TO THE PROGRAMMER WAND. WHILE OBTAINING VENTRICULAR PACING THRESHOLDS HE APPEARED GRAY AND VERY DIAPHORETIC. THE PATIENT WAS PUT ON AN EXAM TABLE AND THEN PLACED IN A SUPINE POSITION WHICH IMPROVED HIS SITUATION. THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL WHERE HE WAS OBSERVED AND RELEASED. THE PHYSICIAN SUSPECTS THE PATIENT EXPERIENCED A NEUROCARDIOGENIC RESPONSE TO THRESHOLD TESTING AND HIS TESTING SHOULD BE PERFORMED IN A SUPINE POSITION GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20608 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L 4269| 4261| S603| 1226| 1290