BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4150902 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16859
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 1, 2013
    Report Date
    August 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WITH PACING INHIBITION HOWEVER THERE WAS NO ASYSTOLE. NOISE EPISODES WERE NOTED IN THE LOG BOOK AND TRENDING SHOWED THAT LOW IMPEDANCE HAS BEEN OBSERVED FOR A YEAR. ALL OTHER MEASUREMENTS WERE WITHIN RANGE. AT THIS TIME, THERE ARE NO PLANNED INTERVENTIONS TO RESOLVE THE ISSUE DUE TO PATIENT¿S CONDITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633619 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K062

    Patients

    Seq Age Sex Outcome Treatment
    1 1233 MO 1270| 1298| 4015| 4017