BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY X4 STRAIGHT

    MDR report key: 16380221 · Received February 15, 2023

    Report

    Report Number
    2124215-2023-06828
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    July 1, 2022
    Report Date
    May 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P010012/S398
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS NOT BEEN RETURNED; THEREFORE A TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITIVELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED INTACT. THE E2 CONDUCTOR RESISTANCE MEASURED AS INTERMITTENT - INDICATING A FRACTURED OR BROKEN CONDUCTOR. FRACTURED E2 CONDUCTOR, LOCATED 18 CM FROM THE TIP END - CURVATURE AREA. THE REPORTED CLINICAL OBSERVATION OF BRADY PACING NOT DELIVERED WHEN REQUIRED AND HIGH CAPTURE THRESHOLDS, WAS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY EXPLANTED DUE TO EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE (GREATER THAN 3,000 OHMS), PACING INHIBITION, HIGH CAPTURE THRESHOLDS. A NEW LEAD WAS IMPLANTED. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE OBSERVED. THE LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY EXPLANTED DUE TO EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE (GREATER THAN 3,000 OHMS), PACING INHIBITION, HIGH CAPTURE THRESHOLDS. A NEW LEAD WAS IMPLANTED. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290219 ACUITY X4 STRAIGHT IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION 4671 504842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H