BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951395 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22863
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    September 10, 2018
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED 12 CM FROM THE TERMINAL PIN WITH ONLY THE PROXIMAL SEGMENT RETURNED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD PORTION¿S ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING DID NOT REVEAL ANY ABNORMALITIES ON THE PROXIMAL SEGMENT THAT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PACING THRESHOLDS HAD RISEN ON THIS RIGHT VENTRICULAR (RV) LEAD SINCE THE IMPLANT PROCEDURE. A LEAD DISLODGEMENT WAS CONFIRMED AND THIS LEAD WAS REPOSITIONED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R