BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 23465903 · Received November 4, 2025

    Report

    Report Number
    1627487-2025-05409
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: QUATTRODE LEAD WIDE SPACED, 90 CM, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6042358". COMMON DEVICE NAME: QUATTRODE LEAD WIDE SPACED, 90 CM, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: T00005709". COMMON DEVICE NAME: QUATTRODE LEAD WIDE SPACED, 90 CM, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: T00005709". BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY DUE TO LEAD MIGRATION. THE ISSUE WAS CONFIRMED VIA X-RAYS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS REPOSITIONED. EFFECTIVE THERAPY RESTORED. NOTE: IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2816459 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD LGW ABBOTT MEDICAL 3169 6009158 05414734406116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS IPG.| SCS LEAD.| SCS LEADX2.