BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 23267518 · Received October 10, 2025

    Report

    Report Number
    3006630150-2025-08661
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729121336
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2208500 MODEL: SC-2208-50 SERIAL: (B)(6) BATCH: 173013. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2208500 MODEL: SC-2208-50 SERIAL: (B)(6) BATCH: 170615.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245462 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 172949 08714729121336

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention