BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 23330801 · Received October 17, 2025

    Report

    Report Number
    3006630150-2025-09237
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 25, 2022
    Report Date
    March 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW YEARS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN:M365SC2218700. MODEL:SC-2218-70. SERIAL:(B)(6). BATCH:5163649. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN:M365SC2218700. MODEL:SC-2218-70. SERIAL:(B)(6). BATCH:7071815. UDI:(B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 25835824. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION ACTIVITIES: 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 A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) LEADS AND CLIK ANCHOR WERE ALSO EXPLANTED DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) LEADS AND CLICK ANCHOR WERE ALSO EXPLANTED DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297992 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 370738 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention