BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 24214975 · Received January 29, 2026

    Report

    Report Number
    1627487-2026-00475
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 29, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406130
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE LEAD KIT, 60CM LENGTH, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 4854206 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED ONE OF THE PATIENT'S LEADS HAS MULTIPLE IMPEDANCES. DIAGNOSTICS SHOW BOTH LOW AND HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CONTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278713 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 4854206 05414734406130

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other SCS IPG| SCS LEAD