BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA ?

    MDR report key: 22891076 · Received August 25, 2025

    Report

    Report Number
    3006630150-2025-06875
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    January 1, 2023
    Report Date
    May 18, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 20711666, MODEL/CATALOG DESCRIPTION LINEAR? 3-6, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER SC-2366-70, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 5099584, MODEL/CATALOG DESCRIPTION LINEAR? 3-6, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 5075180, MODEL/CATALOG DESCRIPTION LINEAR? 3-6, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 5075751, MODEL/CATALOG DESCRIPTION LINEAR? 3-6, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7071691, MODEL/CATALOG DESCRIPTION LINEAR? 3-6, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7071209, MODEL/CATALOG DESCRIPTION LINEAR? 3-6, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-55, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 1077085, MODEL/CATALOG DESCRIPTION NA, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-55, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7020267, MODEL/CATALOG DESCRIPTION NA, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-55, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7020390, MODEL/CATALOG DESCRIPTION NA, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-55, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7020390, MODEL/CATALOG DESCRIPTION NA, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-55, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7020380, MODEL/CATALOG DESCRIPTION NA, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3354-25, SERIAL NUMBER (B)(6), BATCH/LOT NUMBER 7070015 X2, MODEL/CATALOG DESCRIPTION NA, UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM. MULTIPLE REPROGRAMMING SESSIONS WERE PERFORMED HOWEVER ONLY MINIMAL BENEFIT WAS PROVIDED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH ALL THE DEVICES WERE EXPLANTED AND IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47212 PRECISION SPECTRA ? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 169394 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1