BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SQ-RX PULSE GENERATOR

    MDR report key: 21301522 · Received February 4, 2025

    Report

    Report Number
    2124215-2025-05668
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 1, 2014
    Report Date
    February 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NARAYANAN, CHOCKALINGAM A., ET AL. (2024). MAINTENANCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS IN HYPERTROPHIC CARDIOMYOPATHY PATIENTS WITH IATROGENIC LEFT BUNDLE-BRANCH BLOCK AFTER SEPTAL MYECTOMY. J AM HEART ASSOC. 2024;13:E033728. DOI: 10.1161/JAHA.123.033728.

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT THE AUTHORS FOLLOWED A COHORT OF PATIENTS WITH HYPERTROPHIC CARDIOMYOPATHY (HCM) AND IATROGENIC LEFT BUNDLE-BRANCH BLOCK (LBBB) AND SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). THEY DESCRIBE 9 PATIENTS WITH HCM AND S-ICD AND SEPTAL MYECTOMY. S-ICDS WERE IMPLANTED BETWEEN 2014 AND 2021 AND MEAN FOLLOW-UP WAS 44.1 MONTHS. T-WAVE OVERSENSING WAS OBSERVED IN 2 PATIENTS, 1 OF WHOM DEVELOPED A DROP IN R-WAVE AMPLITUDE WHILE SQUATTING WITH 2 INAPPROPRIATE SHOCKS 4 MONTHS AFTER MYECTOMY. THE SENSING VECTOR WAS SUBSEQUENTLY CHANGED FROM PRIMARY TO ALTERNATE WITH NO FURTHER OVERSENSING OR INAPPROPRIATE SHOCKS FOR THE LAST 7 YEARS. TO DATE, NO PATIENTS HAVE REQUIRED EXPLANT OF S-ICD WITH CONVERSION TO A TRANSVENOUS SYSTEM. ONE PATIENT WAS NOTED TO HAVE T-WAVE OVERSENSING IN THE PRIMARY VECTOR AND UNDERWENT VECTOR CHANGE TO ALTERNATE WITH NO OVERSENSING FOR THE LAST 5 YEARS. HE RECENTLY PRESENTED FOR S-ICD GENERATOR REPLACEMENT DUE TO NORMAL BATTERY DEPLETION. GENERATOR CHANGE WAS PERFORMED AND HE CONTINUES WITH S-ICD IMPLANT WITHOUT FURTHER EVENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53274 SQ-RX PULSE GENERATOR IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other