BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 21131912 · Received January 10, 2025

    Report

    Report Number
    1627487-2025-00202
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 23, 2024
    Report Date
    January 10, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7110413 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

    IT WAS REPORTED ONE OF PATIENT'S LEADS HAD FULL HIGH IMPEDANCES. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460616 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 7110413 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS LEAD