BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1962258 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00801
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE ABANDONED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. 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 DURING THE DEVICE REPLACEMENT PROCEDURE, THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS ABANDONED SURGICALLY DUE TO A FRACTURE AT THE SUBCLAVIAN SITE. 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 41 YR 4555| 0158| H217| 4480| N119| 4136| 0148