BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23033100 · Received September 11, 2025

    Report

    Report Number
    3006630150-2025-07509
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    June 19, 2025
    Report Date
    April 3, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7153284. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD WIRES WERE CUT AND REMOVED DURING PATIENTS PREVIOUS SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS DEVICE RELATED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THEY REMOVED THE LEADS, SO EVERYTHING HAS NOW BEEN EXPLANTED. THE EXPLANTED DEVICE, NOTHING TO RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD WIRES WERE CUT AND REMOVED DURING PATIENTS PREVIOUS SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS DEVICE RELATED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT EVERYTHING WAS EXPLANTED. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD WIRES WERE CUT AND REMOVED DURING PATIENT'S PREVIOUS SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS DEVICE RELATED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305442 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7131888 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention