BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 9550086 · Received January 6, 2020

    Report

    Report Number
    2124215-2019-26142
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    November 13, 2019
    Report Date
    January 4, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED DURING A ROUTINE FOLLOW UP APPOINTMENT THIS PACEMAKER DEVICE AND COMPETITORS RV LEAD, HAD NOISE, OVERSENSING ON THE RV CHANNEL, WHICH LEAD TO PACING INHIBITION. THERE WAS AN UNKNOWN DURATION OF ASYSTOLE . THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICE CONSULTANT DISCUSSED HAVING THE PATIENT RETURN TO CLINIC FOR ADDITIONAL EVALUATION OF THE RV LEAD. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17695 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 105922

    Patients

    Seq Age Sex Outcome Treatment
    1