BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 21351996 · Received February 10, 2025

    Report

    Report Number
    1627487-2025-00623
    Event Type
    Injury
    Date Received
    February 10, 2025
    Report Date
    February 10, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 4 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7110366. COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7285630. COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7285630. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609943 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 7110366 05414734406109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS EXT (2)| SCS IPG (1)| SCS LEAD (3)