BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY X4 SPIRAL L

    MDR report key: 18976097 · Received March 25, 2024

    Report

    Report Number
    2124215-2024-18055
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526524592
    PMA / PMN Number
    P010012/S398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW REVEALED INTERMITTENT LEFT VENTRICULAR (LV) LEAD LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, RECOMMENDING CHEST X-RAYS TO CONFIRM LV LEAD POSITIONING. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD WAS SEEN IN CLINIC AND LV CAPTURE WAS CONFIRMED IN THE PROGRAMMED VECTOR. THE SENSED ATRIOVENTRICULAR (SAV) DELAY WAS PROGRAMMED TO 100-200MS AND THE PACED ATRIOVENTRICULAR (PAV) DELAY WAS 70-140 MS, AND AT LEAST ONE BIVENTRICULAR (BIV) PACED COMPLEX WAS OBSERVED FOLLOWING THE ATRIAL PACE (AP) AT THE LOWER RATE LIMIT (LRL). THE FIELD REPRESENTATIVE PROVIDED ELECTROGRAMS (EGMS) AT DIFFERENT RATES, AND A RATE OF 90 BPM SEEMED TO OVERDRIVE THE EARLY BEATS POST-AP. A NUMBER OF AP/BIV PACED COMBINATIONS, INDICATING THE PATIENT EITHER HAD VARIED CONDUCTION OR SLOW PREMATURE VENTRICULAR CONTRACTIONS (PVCS). TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS WERE REVIEWED, AND TS RECOMMENDED ADJUSTING PAV AND SAV TO A MAXIMUM OF 140 MS. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW REVEALED INTERMITTENT LEFT VENTRICULAR (LV) LEAD LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, RECOMMENDING CHEST X-RAYS TO CONFIRM LV LEAD POSITIONING. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558698 ACUITY X4 SPIRAL L IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION 4677 828126 00802526524592

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male