BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1862114 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15881
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 CRM RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING INHIBITION FOR THREE SECONDS. THE FIELD REPRESENTATIVE SUSPECTED THE CAUSE OF THE INHIBITION WAS OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE HOSPITAL. THE PATIENT WAS NOTED AS PACING DEPENDENT, HOWEVER, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening 1298| 4086| 4087