BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041103 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00835
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. 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 ONE DAY POST IMPLANT, THIS RIGHT VENTRICULAR LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY REPLACED WITHOUT ANY ADVERSE PATIENT EFFECTS. IT WAS THOUGHT THIS WAS DUE TO THE PATIENT'S ANATOMY. POST PROCEDURE, ACCEPTABLE LEAD MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143996 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0285

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R