BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2050275 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03207
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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

    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 THIS PATIENT THAT IS IN A NURSING HOME AND HAS SEIZURES, RECENTLY NOTED SOME SUDDEN BLOOD PRESSURE DROPS IN CONJUNCTION WITH SLOW HEART RATE. THESE SUDDEN DROPS IN PRESSURE HAVE LED TO SYNCOPAL EPISODES. THE PATIENTS PHYSICIAN CHANGED THE SEIZURE MEDICATION RECENTLY AND IT IS UNKNOWN IF THAT HAS CONTRIBUTED TO THE SYNCOPE AND PRESSURE DROPS. AT A RECENT DEVICE CHECK HER PACEMAKER WAS FUNCTIONING PROPERLY. TO DATE, THIS DEVICE REMAINS IMPLANTED. .

    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 84 YR Other 4135| 4456| S603