BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 25084710 · Received May 5, 2026

    Report

    Report Number
    3006630150-2026-02880
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729762751
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <MHY, NHL, PJS>. G4: ADDITIONAL PREMARKET / 510(K) # THAT APPLIES TO THE INDICATION OF THIS DEVICE - <P150031>.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) TUNNELING TOOL WAS INTENDED TO BE USED IN AN IMPLANTATION PROCEDURE. UPON OPENING THE PRODUCT IN QUESTION AND ASSEMBLING THE HANDLE AND SHAFT, A VINYL-LIKE MATERIAL WAS OBSERVED WRAPPED AROUND THE SHAFT. CONSEQUENTLY, THIS UNIT WAS NOT UTILIZED, AND INSTEAD, ANOTHER UNIT OF THE SAME MODEL WAS EMPLOYED. GIVEN THAT THE FOREIGN MATERIAL WAS WRAPPED AROUND THE SHAFT, IT IS CONSIDERED UNLIKELY THAT IT BECAME ATTACHED DURING THE UNPACKING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274269 NA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-4254 36786269 08714729762751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown