BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905541 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12068
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT, WHO WAS PACER DEPENDENT, WAS NOT PACING IN DDD MODE AND EXPERIENCED GREATER THAN TWO SECONDS OF ASYSTOLE DURING AN IMPLANT PROCEDURE. THERE WAS ALSO SOME OVERSENSING OF MINUTE VENTILATION SIGNALS ON THE RIGHT VENTRICULAR LEAD IN A BIPOLAR SETTING AS WELL. AFTER REEXAMINING AND SWITCHING THE SYSTEM TO A UNIPOLAR SETTING, PACING RESUMED AND THERE WAS NO OVERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED THAT THESE ALLEGATIONS WERE DUE TO A PROGRAMMING ISSUE AS A BIPOLAR SETTING WILL NOT WORK FOR UNIPOLAR LEADS. THE SYSTEM WAS SUCCESSFULLY IMPLANTED AND LATER CHECKED AND FOUND TO BE WORKING FINE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384718 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K184

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R K184