BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19564359 · Received June 19, 2024

    Report

    Report Number
    3006630150-2024-03945
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 24, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7141687.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS MIDLINE LEAD INCISION WAS OPEN AND DRAINING AND HAD NOT HEALED COMPLETELY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) FOR EVALUATION AND TREATMENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679642 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7141629 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention