BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 24045544 · Received January 12, 2026

    Report

    Report Number
    1627487-2026-00105
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 19, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 6183676.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF HIGH LEAD IMPEDANCES WAS CONFIRMED. THE LEAD WAS RECEIVED COMPLETE. MICROSCOPIC INSPECTION OF THE LEAD REVEALED ALL WIRES WERE BROKEN AT 21.3CM DISTAL TO THE STIMULATION END. ALL CHANNELS MEASURED OPEN DUE TO THE BROKEN WIRES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS UNABLE TO ENTER MRI MODE, PATIENTS LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106708 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 6183676 05415067017246

    Patients

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