BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 18964390 · Received March 22, 2024

    Report

    Report Number
    3006705815-2024-02190
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 22, 2024
    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
    OK, 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 COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(6), SERIAL: (B)(6) BATCH: 7110430.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXISTING LEADS WERE EXPLANTED AND REPLACED RESTORING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756811 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000078986 05415067017246

    Patients

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