BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20812081 · Received November 29, 2024

    Report

    Report Number
    3006630150-2024-08257
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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)(6) BATCH: 7151575.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A LEAD IMPLANT PROCEDURE, THE PATIENTS INCISION WAS NOT HEALING COMPLETELY. THE PATIENT UNDERWENT A DEBRIDEMENT AND CLOSURE OF DEHISCED WOUNDS. DURING POST-SURGICAL FOLLOW UP, IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING SOME DISCHARGE AND ITCHING AT THE INCISION SITES. IT WAS ALSO NOTED THAT THE PATIENTS LEADS HAD MIGRATED, AS SHOWN IN FLUOROSCOPIC IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617959 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7151413 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention