BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 17020065 · Received May 30, 2023

    Report

    Report Number
    3006630150-2023-03046
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 30, 2023
    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

    BLOCK B3: 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: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7073109 / 7073215.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD SITE. SYMPTOM OF INFECTION WAS AN OPEN INCISION SITE. IT WAS UNKNOWN IF INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PHYSICIAN PERFORMED AN INCISION AND DRAINAGE PROCEDURE ON THE WOUND, AND IT WAS CLOSED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449061 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7073098 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention