BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853592 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14964
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 18, 2010
    Report Date
    May 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THIS LEAD WAS REMOVED FROM SERVICE DUE TO THE SAME ISSUE AS REPORTED PREVIOUSLY. TROUBLESHOOTING WAS DONE PRIOR TO THE REVISION PROCEDURE, BUT THE CAUSE OF THE RISE IN IMPEDANCE COULD NOT BE ISOLATED AND THEREFORE THIS LEAD WAS REMOVED FROM SERVICE. FINAL ANALYSIS COULD NOT CONFIRM OR DENY THE DEVICE CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH SHOCK IMPEDANCE >125 OHMS. IMPEDANCE WAS 70-75 OHMS AT IMPLANT AND HAS VARIED SINCE. THE DEVICE WAS PROGRAMMED DISTAL COIL TO CAN. TECHNICAL SERVICES (TS) DISCUSSED DELIVERING A COMMANDED 1.1 JOULE (J) SHOCK AND A MAXIMUM ENERGY SHOCK TO TEST THE INTEGRITY OF THE SYSTEM. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention 4076| 0180| E110