BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20436528 · Received October 13, 2024

    Report

    Report Number
    3006630150-2024-06913
    Event Type
    Injury
    Date Received
    October 13, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS AFTER THE IMPLANT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC; UPN: M365SC14160; MODEL: SC-1416; SERIAL: (B)(6); BATCH: 225289. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700; MODEL: SC-2218-70; SERIAL: 7102238; BATCH: 7102238. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43160; MODEL: SC-4316; SERIAL: (B)(6); BATCH: 33651622. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: M365SC43180; MODEL: SC-4318; SERIAL: (B)(6); BATCH: 33872611.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. SYMPTOMS OF SWELLING, SENSITIVITY, WARM TO TOUCH, AND FEVER WERE NOTED. PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208199 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7101920 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention