BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA ?

    MDR report key: 22031995 · Received May 15, 2025

    Report

    Report Number
    3006630150-2025-03400
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 14, 2024
    Report Date
    May 25, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION? CX UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 20070696, UDI: (B)(4). BRAND NAME: LINEAR? 3-6 UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5112224, 5120408, UDI: (B)(4). BRAND NAME: LINEAR? 3-6 UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 19576400, UDI: (B)(4). BRAND NAME: NA UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 1097157, 7070116, 7073309, 7073237 UDI: (B)(4). BRAND NAME: LINEAR? ST UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 19562248, UDI: (B)(4). BRAND NAME: LINEAR? 3-6 UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 19660475, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF PAIN RELIEF FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING WITHOUT ISSUE. THE EXPLANTED DEVICES WILL NOT BE RETURNED DUE TO THE HOSPITAL POLICY OF NOT RELEASING CONTAMINATED MEDICAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473679 PRECISION SPECTRA ? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 19781129 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1