BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4232393 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19501
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CLINICIAN CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO DISCUSS THAT THE PATIENT'S PREMATURE VENTRICULAR CONTRACTION (PVC) SEEM TO INITIATE SUDDEN BRADY RESPONSE (SBR) EVENTS. TS DISCUSSED THE ALGORTHYM AND INQUIRED IF THE CLINICIAN FEELS SBR SHOULD BE PROGRAMMED ON IN THE DEVICE BASED UPON THE PATIENT'S CONDITION. THE CLINICIAN NOTED THAT THE PATIENT HAS A HISTORY OF SYNCOPE, THUS THEY FELT IT WAS BEST TO LEAVE IT PROGRAMMED ON. IT WAS ALSO NOTED THAT THESE EVENTS SEEM TO BE GROUP ON CERTAIN DAYS. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE SYNCOPAL EPISODES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715786 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening MISMATCH| K173| 5076