BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10647712 · Received October 8, 2020

    Report

    Report Number
    3006630150-2020-04708
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEARLEADS: UPN: (B)(4). MODEL: SC-2352-70. SERIAL: (B)(4). BATCH: 7070272.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT HAD ANESTHESIA ISSUES. THE IMPLANT PROCEDURE WAS ABORTED AFTER THE LEADS WERE PLACED. THE PATIENT WAS FLIPPED TO ENSURE BREATHING AND TO BE OUT OF THE ANESTHESIA. THE LEADS WERE REMOVED, THE IMPLANT SITE WAS CLEANED AND CLOSED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113533 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7071312 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention