BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 2910033 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15165
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 ONE DAY POST IMPLANT, PACING WAS OCCURRING AT MAXIMUM TRACKING RATE (MTR), LIKELY A RESULT OF RS DOWN. PVC'S WERE OCCURRING WITH PAUSES. RS DOWN WAS PROGRAMMED OFF AND RVAC WAS PROGRAMMED ON. NO PATIENT SYMPTOMS OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18782 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1