BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953983 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24068
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. AS NO RETURN OF PRODUCT IS INTENDED, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION REVEALED A VENTRICULAR TACHYCARDIA EPISODE AND THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE. IT WAS THOUGHT THE NOISE WAS DUE TO A LEAD FRACTURE. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS REMOVED AND REPLACED. UPON REMOVAL A VISUAL INSPECTION CONFIRMED THIS LEAD WAS FRACTURED. NO RETURN OF PRODUCT IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention