BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170277 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09957
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED 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 AN ELECTIVE DEVICE REPLACEMENT PROCEDURE EXTRACTION OF THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS UNSUCCESSFUL. THE LEAD WAS ABANDONED SURGICALLY DUE TO RISING THRESHOLD MEASUREMENTS, LOSS OF CAPTURE AND IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. 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 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| R H135| 4513| 4087| H219| 0158