BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2172854 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10373
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 FROM THE LOCAL AREA SALES REPRESENTATIVE THAT THIS PATIENT'S DEVICE/LEAD SYSTEM WAS ELECTIVELY EXPLANTED. THE SYSTEM WAS EXPLANTED BECAUSE THE PATIENT'S INCISION SITE WAS NOT HEALING PROPERLY. THE PATIENT WAS DISCHARGED WITH AN EXTERNAL LIFEVEST. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R 4135| 0157| E110