BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 25260077 · Received May 22, 2026

    Report

    Report Number
    3006630150-2026-03395
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729121732
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: LGW - QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BREAK IN THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574402 NA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-4206 35307682 08714729121732

    Patients

    Seq Age Sex Outcome Treatment
    1