BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3053109 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04570
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS SUCCESSFULLY IMPLANTED. POST IMPLANT, A ATRIAL NODE ABLATION PROCEDURE WAS PERFORMED. WHEN THE RADIO FREQUENCY (RF) WAS STARTED, A FIVE SECOND PACING PAUSE WAS NOTED. THE RF WAS STOPPED AND PACING COMMENDED. RF WAS APPLIED AGAIN AND NO PACING PAUSES WERE NOTED. THE DEVICE WAS PROGRAMMED TO VVI 30BPM PACING MODE. AN INTERNAL TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED AND PROVIDED THE INSTRUCTIONS FOR PRECAUTIONS WHEN PERFORMING RF ABLATION DESIGNED TO PREVENT PACING INHIBITION. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154601 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J172

    Patients

    Seq Age Sex Outcome Treatment
    1