BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 24322811 · Received February 12, 2026

    Report

    Report Number
    3006630150-2026-00851
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    January 1, 2022
    Report Date
    May 4, 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
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 4 YEARS AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500 MODEL: SC-8216-50 SERIAL: (B)(6). BATCH: 20903783 UDI: (B)(4). SC-1200 (SN (B)(6). SC-8216-50 (SN (B)(6). INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 4 YEARS AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 20903783, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. UNABLE TO RETURN PRODUCTS AS THIS DID NOT OCCUR LOCALLY AND LOCAL REPRESENTATIVES WERE NOT INVOLVED IN EXPLANT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. UNABLE TO RETURN PRODUCTS AS THIS DID NOT OCCUR LOCALLY AND LOCAL REPRESENTATIVES WERE NOT INVOLVED IN EXPLANT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415707 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 21007648 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1