BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3053135 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04363
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING THIS CASE WAS SENT TO TECHNICAL SERVICES FOR REVIEW. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING FOR THIS PARTICULAR ISSUE. AT THIS TIME THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS NOT POSSIBLE TO ESTABLISH TELEMETRY WITH THE DEVICE THUS IT WAS NOT POSSIBLE TO INTERROGATE THIS DEVICE. THE PROGRAMMER WAS ABLE TO INTERROGATE OTHER DEVICE, THUS THE ISSUE WAS WITH THIS DEVICE. THE DEVICE REMAINS IMPLANTED . NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156412 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4087| 4459| S602