BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 18536362 · Received January 18, 2024

    Report

    Report Number
    1627487-2024-00320
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 26, 2023
    Report Date
    February 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION 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 LEAD, MODEL: 3189, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8100350.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW, THE ISSUE SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) AS THE LEADS WERE NOT SURGICALLY REVISED AS PROGRAMMING WAS ABLE TO RESTORE EFFECTIVE THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852938 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 8100350 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS IPG (X1)| SCS LEAD (X1)| SCS LEAD ANCHOR (X2)