BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 21686541 · Received March 25, 2025

    Report

    Report Number
    3006630150-2025-01825
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    January 1, 2022
    Report Date
    October 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 21510764.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 21510764.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT HAD THE ENTIRE SPINAL CORD STIMULATION SYSTEM EXPLANTED AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT HAD THE ENTIRE SPINAL CORD STIMULATION SYSTEM EXPLANTED AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132025 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 202968 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention