BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1873867 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17751
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT CALLED TECHNICAL SERVICES (TS) STATING THAT A NON BOSTON SCIENTIFIC PERSON LAST INTERROGATED HIS DEVICE AND CHANGED SOME SETTINGS. HE ALSO STATED THAT HE HAS OCCASIONAL FAINTING SPELLS, BUT HAS HAD THEM BEFORE. IT IS UNKNOWN IF THE SYNCOPE IS DEVICE RELATED OR WHAT THE PROGRAMMING CHANGES WERE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 87 YR S603| 4136| 4135