BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION?

    MDR report key: 21908314 · Received April 25, 2025

    Report

    Report Number
    3006630150-2025-02747
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 25, 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
    MA, 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 NON-FUNCTIONAL. 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
    502184 PRECISION? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 181170 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention