BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043264 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02107
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 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 THE LEAD WAS NOT ABLE TO BE RETURNED, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. 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 DURING A ROUTINE DEVICE CHECK, THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS. A LEAD FRACTURE WAS SUSPECTED, AND A REVISION PROCEDURE WAS PERFORMED THE FOLLOWING DAY. THE LEAD WAS DISCONNECTED FROM THE DEVICE AND TESTED ON THE PACING SYSTEM ANALYZER (PSA), WHERE THE PACING IMPEDANCE WAS 4,000 OHMS. THE PACING THRESHOLD AND SENSING MEASUREMENTS WERE NORMAL, AND NO NOISE WAS FOUND ON THE ELECTROGRAMS. THE LEAD WAS SURGICALLY ABANDONED AND A NEW RV DEFIBRILLATION LEAD WAS IMPLANTED. THE DEVICE WAS ALSO REPLACED DURING THIS PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145850 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R