BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2173788 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10982
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT CONTACTED OUR MEDICAL RECORD DEPARTMENT AND STATED THAT HE BELIEVES THE DEVICE IS NOT FUNCTIONING APPROPRIATELY AND NEEDS TO BE REPROGRAMMED. THE PATIENT DID NOT WANT TO BE SENT TO THE TECHNICAL SERVICE DEPARTMENT TO DISCUSS HIS ALLEGATION FURTHER. AN EMAIL WAS SENT TO THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4087| 4137| S606