BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 20536020 · Received October 25, 2024

    Report

    Report Number
    2124215-2024-67060
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    June 1, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526264993
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS LEAD HAD SAFETY SWITCH TO UNIPOLAR WHICH LED TO OVERSENSING OF THE PECTORAL MUSCLE WHICH INHIBITED SOME PACING. WHEN THE LEAD WAS REPROGRAMMED BACK TO BIPOLAR, LOSS PACING CAPTURE WAS NOTED. THE PHYSICIAN DECIDED TO SURGICALLY ABANDON AND REPLACED THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENT WHICH LED TO THE SAFETY SWITCH AND HAD BEEN THAT WAY SINCE JUNE. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS LEAD HAD SAFETY SWITCH TO UNIPOLAR WHICH LED TO OVERSENSING OF THE PECTORAL MUSCLE WHICH INHIBITED SOME PACING. WHEN THE LEAD WAS REPROGRAMMED BACK TO BIPOLAR, LOSS PACING CAPTURE WAS NOTED. THE PHYSICIAN DECIDED TO SURGICALLY ABANDON AND REPLACE THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818965 FINELINE II EZ STEROX IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4470 794619 00802526264993

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H