BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 2942511 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-01938
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS PRESENTED TO THE HOSPITAL WITH A LOW HEART RATE AND IT WAS FURTHER NOTED THAT THE PATIENT HAD HIGH PACING THRESHOLD OUTPUTS. THE PHYSICIAN DECIDED TO TREAT THE INFECTION AND LEAVE THE DEVICE AT ITS CURRENT SETTING WITH HIGH OUTPUTS. THE LEAD WAS EVENTUALLY EXPLANTED FROM THE PATIENT DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46079 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Hospitalization| L| R 1194| K062| 4261| 0460