BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053253 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04931
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. 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 THIS RIGHT VENTRICULAR LEAD PLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. A REVIEW OF THE DATA REVEALED VARIABLE SHOCK IMPEDANCE MEASUREMENTS DURING THE PAST YEAR AND ONLY ONE OUT OF RANGE MEASUREMENT. IN ADDITION, WHEN THE LEAD WAS IMPLANTED IN 2007, NORMAL SENSING MEASUREMENTS OFF >6 MV WERE OBTAINED. SENSING DECREASED TO 2.9 TO 3.8 MV. DURING AN INTENDED DEVICE REPLACEMENT PROCEDURE, A DECISION WAS MADE TO LEAVE THIS LEAD IMPLANTED AND FURTHER MONITOR. MOVEMENT AFTER SURGERY DID NOT REVEAL NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154618 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L