BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 14680236 · Received June 13, 2022

    Report

    Report Number
    3006630150-2022-02834
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 23, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7073199/7072903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD INCISION SITE. IT WAS NOTED THAT THE PATIENTS LEADS WERE VISIBLE AND WAS OUTSIDE THE SKIN; AND THERE WAS DISCHARGED FROM THE INCISIONS SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED AND WAS UNKNOWN AS TO WHAT CAUSED THE INFECTION. THE PATIENTS WOULD WAS WASHED OUT AND THE PATIENT WAS GIVEN AN INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. IT WAS NOTED THAT THE PATIENT WILL LIKELY BE ON A LONG TERM COURSE OF ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879344 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7072262 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention