BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SQ-RX PULSE GENERATOR

    MDR report key: 21963616 · Received May 5, 2025

    Report

    Report Number
    2124215-2025-28693
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    December 5, 2023
    Report Date
    May 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HORI, YUICHI, ET AL. (2024). IMPORTANCE OF VISUALIZING THE ANATOMICAL LOCATION OF THE LATISSIMUS DORSI MUSCLE USING COMPUTED TOMOGRAPHY FOR A ROBUST REIMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR. JOURNAL OF CARDIOLOGY CASES 30 (2024) 147-149. HTTPS://DOI.ORG/10.1016/J.JCCASE.2024.07.003. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT THE AUTHORS USED THE SUBMUSCULAR APPROACH HAS BEEN USED AS AN ALTERNATIVE TECHNIQUE FOR THE IMPLANT POSITION OF A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). AN S-ICD MIGRATED AND CAUSED THE PATIENTS SKIN TO THIN, WITH THE PATIENT EXPERIENCING PAIN AS A RESULT. A CHEST COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE DEVICE WAS REPOSITIONED. AFTERWARDS, A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED SUCCESSFULLY. ADDITIONALLY, A CT SCAN AND X-RAY IMAGING WERE PERFORMED AFTER THE REVISION TO VERIFY THE S-ICD POSITION. THIS S-ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443635 SQ-RX PULSE GENERATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention| H