BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16084059 · Received January 2, 2023

    Report

    Report Number
    3006630150-2022-07421
    Event Type
    Injury
    Date Received
    January 2, 2023
    Date of Event
    December 8, 2022
    Report Date
    January 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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)(4). BATCH: 7112282. PRODUCT FAMILY: SCS-IPG-R-MRI: UPN: M365SC12000. MODEL: SC-1200. SERIAL: (B)(4). BATCH: 376894.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. SYMPTOMS OF REDNESS AND PUSS AT THE SITE WERE NOTED. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PHYSICIAN BELIEVED THAT THE CAUSE OF INFECTION WAS THE PATIENTS SANITARY ISSUES AND NON COMPLIANCE. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563286 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7111472 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention