BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151407 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07134
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    March 19, 2013
    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

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WILL CONTINUE TO BE MONITORED FOR NOW. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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

    AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED A HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENT. THERE WERE NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEE MADE. THE LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R E102| 0147