BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1771418 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12520
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 2010
    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 EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FIVE SECONDS OF PACING INHIBITION WAS OBSERVED DURING AN AUTO CAPTURE COMMANDED TEST. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT AND THE TEST WAS REPEATED WITH NO FURTHER OBSERVATION OF PACING INHIBITION. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THAT THIS IS NOT A TYPICAL RESULT OF THE AUTO CAPTURE COMMAND TEST AND TOLD THE CLINICIAN TO CONSIDER PROGRAMMING A FIXED OUTPUT FOR THE RIGHT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 405-03| 294-03| 1284| 431-04| 1290| 284-05