BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2171625 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10611
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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, ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE PACEMAKER PASSED OUT. IT WAS NOTED THAT THERE WERE NO RELATED EVENTS IN THE ARRHYTHMIA LOGBOOK AND THE PHYSICIAN WAS OPTING TO CONTINUE TO MONITOR THE PATIENT. IT WAS ALSO NOTED THAT THIS PATIENT WAS VERY ILL, NON-CARDIAC RELATED. ADDITIONALLY, IT WAS NOTED THAT THE CLINIC WAS NOT ABLE TO INTERROGATE THIS DEVICE AND WAS OBSERVING AN "OUT OF RANGE, TELEMETRY NOISE" MESSAGE. TECHNICAL SERVICES (TS) ADVISED SEVERAL DIFFERENT TROUBLESHOOTING OPTIONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S203

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening S203| 4087| 4088