BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI?

    MDR report key: 24831782 · Received April 9, 2026

    Report

    Report Number
    3006630150-2026-02188
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 28, 2023
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-70. SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7070265 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM UNIQUE IDENTIFIER (UDI)#: (B)(4) MODEL NUMBER/CATALOG NUMBER: SC-2352-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7070209 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM UNIQUE IDENTIFIER (UDI)#: (B)(4) MODEL NUMBER/CATALOG NUMBER: SC-8216-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 14160667 MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM UNIQUE IDENTIFIER (UDI)#: (B)(4) INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE, HOWEVER RESPONSE WAS NOT RECEIVED. 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. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7070265, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7070209, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-8216-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 14160667, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132034 PRECISION NOVI? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1140 202639 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1