BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 22716198 · Received August 5, 2025

    Report

    Report Number
    1627487-2025-03873
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 14, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3189 , UDI: (B)(4), SERIAL: (B)(6); BATCH:6933657.

    Additional Manufacturer Narrative · 0

    COMPLAINT WAS CONFIRMED FOR IMPEDANCE ABNORMAL. AS RECEIVED, VISUAL INSPECTION OF THE LEAD WAS FOUND WITH ALL THE INTERNAL WIRES BROKEN THE ALL-BROKEN WIRES WILL CAUSE HIGH IMPEDANCE ON LEAD, WHICH WILL CAUSE THE LOSS OF THERAPY. THE CAUSE FOR THE EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE/NO THERAPY IN THE RIGHT SIDE. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON ONE OF THE LEADS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OP. INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD HAD THE HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2634730 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 6826956 05414734401715

    Patients

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