BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 25179251 · Received May 14, 2026

    Report

    Report Number
    3006705815-2026-03058
    Event Type
    Injury
    Date Received
    May 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    BROKEN LEADS. ON (B)(6) 2026, PATIENT CALLED TS ABOUT ESU LETTER (TS-2882958), BUT PATIENT STATED THEY GOT A SYSTEM REPLACEMENT TO MEDTRONIC ON (B)(6) 2023 BECAUSE THEIR LEADS WERE BROKEN. TSE EMAILED PDT TO UPDATE THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369815 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000048018 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS IPG.