BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4221080 · Received November 3, 2014

    Report

    Report Number
    2124215-2014-19265
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM REMAINS IN SERVICE. 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 THE PATIENT WITH THIS PACEMAKER STATED THAT REPOSITIONING WAS PERFORMED AS THE SYSTEM WAS NOT PLACED IN RIGHT. THE PATIENT WAS EXPERIENCING PAIN AND STATED THAT THE LEADS MOVED AND WERE COMING OUT OF THE SKIN OF WHICH A REVISION WAS SAID TO HAVE BEEN PERFORMED. THE PATIENT ALSO COMPLAINED THAT MORE FLUTTERS WERE OCCURING AFTER THE DEVICE WAS REPOSITIONED. THE PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703133 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4479| K173| 4456