BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18111561 · Received November 10, 2023

    Report

    Report Number
    3006630150-2023-06934
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7091574; PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43160, MODEL: SC-4316, BATCH: 31979845/26552301.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS CERVICAL MIDLINE INCISION SITE APPEARED RED AND WAS NOT CLOSING PROPERLY. IT WAS ALSO NOTED THAT THERE WAS A LUMP ON THE LEFT SIDE OF THE MIDLINE INCISION SITE, WHICH WAS THE CLIK ANCHORS. THE PHYSICIAN GAVE THE PATIENT TWO ROUNDS OF ANTIBIOTICS AND PERFORMED A WOUND FLUSH OUT. THE PHYSICIAN DECIDED NOT TO MOVE THE ANCHORS AS ORIGINALLY ANTICIPATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804149 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7091518 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention