BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1851885 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14392
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE PRODUCT IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE CLINICIAN WAS UNABLE TO OBTAIN THE R-WAVE OR IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THE CLINICIAN TO PROGRAM THE DEVICE TO DO IN ORDER TO OBTAIN THE IMPEDANCE MEASUREMENT AND TO PERFORM A MANUAL MEASUREMENT FOR THE R-WAVES. IT WAS NOTED THAT THE DEVICE WAS SENSING APPROPRIATELY. DURING THE CALL, THE CLINICIAN ALSO STATED THAT THE PATIENT HAS AN INFECTION. NO FURTHER INFORMATION WAS GIVEN AS TO THE LOCATION OF OR COURSE OF ACTION TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening 1291| 4087| 4469