BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953732 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24563
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    October 15, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED THAT THE LEAD HAD LIKELY PERFORATED THE RIGHT VENTRICLE. A REVISION PROCEDURE WAS PERFORMED WHERE A PORTION OF THE EXISTING RV LEAD WAS SURGICALLY ABANDONED DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS AND SUSPECTED PERFORATION. SINCE RV THRESHOLD AND SENSING MEASUREMENTS HAVE BEEN STABLE AND THE LEAD WAS IMPLANTED APPROXIMATELY EIGHT YEARS EARLIER, IT IS UNKNOWN WHEN THE PERFORATION OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS THAT WAS ABLE TO BE REPRODUCED WHEN THE PATIENT RAISED THEIR ARMS. THE PHYSICIAN IS STILL CONTEMPLATING IF HE WILL PERFORM A LEAD REVISION PROCEDURE. 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 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)