BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION?

    MDR report key: 22415668 · Received July 7, 2025

    Report

    Report Number
    3006630150-2025-05218
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    May 8, 2024
    Report Date
    July 7, 2025
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: LGW - QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER CHARGING. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152763 PRECISION? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 15035003 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention