BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION?

    MDR report key: 23288092 · Received October 15, 2025

    Report

    Report Number
    3006630150-2025-08781
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 1, 2025
    Report Date
    February 7, 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
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): QRB.

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): QRB.

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY, AND DIFFICULTY CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM, WHICH WAS FULLY DEPLETED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED AND IS DOING WILL POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY, AND DIFFICULTY CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM, WHICH WAS FULLY DEPLETED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED, AND IS DOING WILL POST OPERATIVELY. IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS RETAINED BY THE FACILITY AND CANNOT BE LOCATED, THEREFORE THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY, AND DIFFICULTY CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM, WHICH WAS FULLY DEPLETED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED, AND THE IS DOING WILL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609025 PRECISION? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 15415896 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention