BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 18454262 · Received January 5, 2024

    Report

    Report Number
    1627487-2024-00119
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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: OCTRODE LEAD KIT, 90CM LENGTH, MODEL: 3189, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8090562

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE RIGHT LEAD WAS EXPLANTED, REPLACED AND MOVED MORE TO THE RIGHT TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY. IT IS UNKNOWN WHICH LEAD IS LIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568936 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 8090562 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHOR (2).| SCS IPG.| SCS LEAD.