BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053282 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04998
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD AND DEVICE REMAIN 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 REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN. A FOLLOW UP VISIT WAS PERFORMED. IN ADDITION TO THE OUT OF RANGE IMPEDANCE MEASUREMENTS; ISOMETRICS REVEALED SENSING ISSUES. AN X-RAY REVEALED THE IS-1 PIN WAS NOT FULLY INSERTED. VALSALVA MANEUVERS WERE PERFORMED RESULTING IN NOISE AND ARTIFACTS. IMPEDANCE MEASUREMENTS REMAINED OUT OF RANGE. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS REMOVED AND REINSERTED INTO THE DEVICE HEADER. AFTER THE CONNECTION WAS VERIFIED, ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154707 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R