BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 23903688 · Received December 28, 2025

    Report

    Report Number
    3006705815-2025-20464
    Event Type
    Injury
    Date Received
    December 28, 2025
    Date of Event
    December 3, 2025
    Report Date
    March 22, 2026
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    B3: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI:(B)(4), SERIAL:(B)(6), BATCH: 7110413.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY AND WAS UNABLE TO ENTER MRI MODE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282795 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000078801 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS ANCHOR (X2).| SCS IPG.