BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17122332 · Received June 13, 2023

    Report

    Report Number
    3006630150-2023-03356
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    April 15, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC221850E0. MODEL: SC-2218-50E. SERIAL: (B)(4). BATCH: 7121404.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE HIP DURING THE TRIAL PERIOD. IT WAS ALSO NOTED THAT THE LEFT LEAD INSERTION SITE WAS SLIGHTLY RED. THE PATIENT WAS GIVEN AN ANTIBIOTIC OINTMENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957127 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 7115740 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention