BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION?

    MDR report key: 24534579 · Received March 6, 2026

    Report

    Report Number
    3006630150-2026-01328
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    October 9, 2025
    Report Date
    May 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315751 PRECISION? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 13648027 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention