BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION?

    MDR report key: 22572560 · Received July 22, 2025

    Report

    Report Number
    3006630150-2025-05769
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 30, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB.

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL MDR IN BLOCK: H6. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NO LONGER CHARGE OR TURN ON DESPITE CYCLE CHARGING ATTEMPTS. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NO LONGER CHARGE OR TURN ON DESPITE CYCLE CHARGING ATTEMPTS. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466095 PRECISION? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 16277352 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention