BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 17218072 · Received June 28, 2023

    Report

    Report Number
    2124215-2023-33692
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526601811
    PMA / PMN Number
    P910073/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW DAYS AFTER IT WAS IMPLANTED THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED AN INCREASE IN CAPTURE THRESHOLD MEASUREMENTS AND HAD ITS IMPEDANCE MEASUREMENTS DROP, SO IT WAS EXAMINED BY X-RAY IMAGING WITH A MICRO DISLODGMENT SUSPECTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS BEEN RETURNED AND WAS ANALYZED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW DAYS AFTER IT WAS IMPLANTED THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED AN INCREASE IN CAPTURE THRESHOLD MEASUREMENTS AND HAD ITS IMPEDANCE MEASUREMENTS DROP, SO IT WAS EXAMINED BY X-RAY IMAGING WITH A MICRO DISLODGMENT SUSPECTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158472 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0273 122132 00802526601811

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization| R