BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211303 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07982
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 13, 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

    AS OF THIS DATE, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT 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.

    Description of Event or Problem · 1

    APPROXIMATELY ONE WEEK LATER, A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE REPLACEMENT LEAD WAS IMPLANTED FROM THE PATIENT'S RIGHT SIDE DUE TO THE LEFT SIDE CLOSED VENOUS ACCESS. IN ADDITION, THE DEVICE WAS ALSO REPLACED WITH INDUCTION TESTING AND SUCCESSFUL CONVERSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS. TRENDING REVEALED THE IMPEDANCE MEASUREMENTS HAVE DECREASED DURING THE PAST FEW MONTHS. IN ADDITION, SIX EPISODES OF NOISE WERE DISPLAYED. SHOCK IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE. A LEAD REVISION IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WITH THIS LEAD IS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310968 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R