BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI?

    MDR report key: 25133634 · Received May 10, 2026

    Report

    Report Number
    3006630150-2026-03032
    Event Type
    Injury
    Date Received
    May 10, 2026
    Date of Event
    June 23, 2018
    Report Date
    May 10, 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
    KY, 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-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5040354 / 5028152. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4316. BATCH/LOT NUMBER: 22006329. MODEL/CATALOG DESCRIPTION: CLIK ANCHOR. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS PAIN WAS AT A TOLERABLE LEVEL, HOWEVER, STIMULATION WAS NOT SATISFACTORY. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490011 PRECISION NOVI? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1140 21660367 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1