BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 24405215 · Received February 20, 2026

    Report

    Report Number
    2124215-2026-09673
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 21, 2026
    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
    PR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO B5. F10 AND H6 UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT, GREATER THAN 3000 OHMS. IT WAS NOTED THE PATIENT EXPERIENCED PRESYNCOPE SYMPTOMS THEN EXPERIENCED SYNCOPE. ALSO, THE FIELD REPRESENTATIVE (REP) OBSERVED EVENTS OF PACING BELOW THE LOWER RATE LIMIT (LRL). THIS CRT-D WAS OVERSENSING NOISE ON THE RA CHANNEL, CAUSING BRADY PACING TO NOT BE DELIVERED WHEN REQUIRED. IT WAS NOTED THE LONGEST PAUSE WAS 1.5 SECONDS WITH A LRL OF 50 BEATS PER MINUTE (BPM). THE REP REPROGRAMMED THE DEVICE AND TURNED ON THE BIVENTRICULAR (BIV) TRIGGER. DURING A DEVICE REPLACEMENT AND LEAD REVISION PROCEDURE, IT WAS DISCOVERED THIS RA LEAD WAS FRACTURED. THIS RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT, GREATER THAN 3000 OHMS. IT WAS NOTED THE PATIENT EXPERIENCED PRESYNCOPE SYMPTOMS THEN EXPERIENCED SYNCOPE. ALSO, THE FIELD REPRESENTATIVE (REP) OBSERVED EVENTS OF PACING BELOW THE LOWER RATE LIMIT (LRL). THIS CRT-D WAS OVERSENSING NOISE ON THE RA CHANNEL, CAUSING BRADY PACING TO NOT BE DELIVERED WHEN REQUIRED. IT WAS NOTED THE LONGEST PAUSE WAS 1.5 SECONDS WITH A LRL OF 50 BEATS PER MINUTE (BPM). THE REP REPROGRAMMED THE DEVICE AND TURNED ON THE BIVENTRICULAR (BIV) TRIGGER. DURING A DEVICE REPLACEMENT AND LEAD REVISION PROCEDURE, IT WAS DISCOVERED THIS RA LEAD WAS FRACTURED. THIS RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT ALSO EXPERIENCED WEAKNESS AT THE TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536803 FINELINE II EZ STEROX IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4470 741990 00802526264993

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Hospitalization| R