BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 19424416 · Received May 30, 2024

    Report

    Report Number
    1627487-2024-08779
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 2 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: 3186, UDI: (B)(4), SERIAL: (B)(4), BATCH: 6151981. 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
    1149519 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 5990552

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other SCS IPG X 1| SCS LEAD X 1