BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210390 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08038
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 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, NO RETURN OF PRODUCT IS INTENDED AS THE LEAD REMAINS IMPLANTED AND ABANDONED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS RIGHT VENTRICULAR LEAD AND DEVICE DISPLAYED A LOW OUT OF RANGE IMPEDANCE MEASUREMENT. IN ADDITION, THE LEAD DISPLAYED NOISE. PACING AND SENSING MEASUREMENTS WERE NORMAL. SIMPLE LEFT ARM MOVEMENTS REPRODUCED THE NOISE. AN X-RAY DID NOT REVEAL ANY LEAD FRACTURE. A DECISION WAS MADE TO REPLACE THIS LEAD. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311223 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R