BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3212635 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09349
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED WITH NO FURTHER COMPLICATIONS. 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 PACEMAKER HAD BEEN SUCCESSFULLY IMPLANTED, WITH ALL TESTING COMPLETED AND NO ISSUES OBSERVED. WHILE THE PHYSICIAN WAS CLOSING THE POCKET, THE PATIENT COMPLAINED OF FEELING DIZZY AND THEN EXPERIENCED ASYSTOLE. IT WAS NOTED THAT THIS PACEMAKER WAS NOMINALLY PROGRAMMED IN A UNIPOLAR CONFIGURATION, AND BECAUSE THE DEVICE WAS NOT YET IN FULL CONTACT WITH THE POCKET, PACING WAS NOT BEING PROVIDED. THIS RESULTED IN THE EPISODE OF ASYSTOLE. ONCE THE DEVICE WAS IN CONTACT WITH THE POCKET, THE DEVICE BEGAN PACING. THE PATIENT WAS FOLLOWED IN THE CARDIAC UNIT FOR ONE HOUR AFTER IMPLANT, AND THE DEVICE WAS THEN PROGRAMMED TO THE BIPOLAR CONFIGURATION. ALL POST-OPERATIVE TESTING WAS PERFORMED, WITH NORMAL LEAD MEASUREMENTS AND NO FURTHER ISSUES OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312790 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening