BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 2942521 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-01006
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 PRODUCT WAS PART OF A PATIENT INFECTION. THE STATUS OF THE PRODUCT IS UNKNOWN AS ADDITIONAL INFORMATION COULD NOT BE OBTAINED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46119 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening 4479| K173| 4136