BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3586954 · Received January 22, 2014

    Report

    Report Number
    2124215-2013-22045
    Event Type
    Injury
    Date Received
    January 22, 2014
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WITH AN IMPLANTABLE PACEMAKER EXHIBITED SUDDEN BRADY RESPONSE (SBR) ALONG WITH SYNCOPE EPISODE WHICH OCCURRED WITH AV SEARCH HYSTERESIS. LOWER RATE LIMIT (LRL) WAS AT 70 PPM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS SUCH AS MODIFYING THE LRL AND THERAPY RATE OFFSET. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN BELIEVED THAT THE PATIENT'S SYMPTOMS COULD HAVE BEEN DUE TO THE ATRIOVENTRICULAR (AV) DELAY STRETCHING OUT TOO FAR. HYSTERESIS WAS DEACTIVATED AND MODIFIED THE SBR BY EXTENDING THE DURATION. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51166 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening K173| 4136| 4135