BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 20868179 · Received December 6, 2024

    Report

    Report Number
    3006630150-2024-08507
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4 UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082059.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A SUSPECTED INFECTION OF THE LEADS DURING THE SPINAL CORD STIMULATION (SCS) TRIAL PERIOD. THE PATIENT WAS HOSPITALIZED, AND THE TRIAL LEADS WERE REMOVED. THE EVENT WAS ASSESSED AS BEING RELATED TO THE DEVICE AND HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE. CULTIVE CONFIRMED THE INFECTION OF S. EPIDERMIDIS. THE OUTCOME OF THE EVENT HAS BEEN REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120001 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7082057 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention