BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 18463598 · Received January 8, 2024

    Report

    Report Number
    1627487-2024-00135
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 21, 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: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF TWO LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6151981.

    Additional Manufacturer Narrative · 0

    THE EVENT OF LEAD REVISION WAS REPORTED TO ABBOTT. THE PATIENT'S LEFT SCS CERVICAL LEAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PATIENT'S LEFT LEAD WAS EXPLANTED, REPLACED, AND THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER:1627487-2024-00134. IT WAS REPORTED THAT THE PATIENT'S LEFT SCS CERVICAL LEAD MIGRATED AND FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE PATIENT'S LEFT LEAD WAS EXPLANTED, REPLACED, AND THERAPY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949970 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 6151980 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS IPG(X1).| SCS LEAD (X1).