BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 13188254 · Received January 7, 2022

    Report

    Report Number
    3006630150-2021-07509
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). LOT: 7082146

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION LEAD IMPLANT PROCEDURE, WITHIN 15 MINUTES OF WAKING UP IN RECOVERY, THE PATIENT WAS UNABLE TO MOVE HER LEGS. A COMPUTED TOMOGRAPHY (CT) MYELOGRAM SCAN REVEALED A HEMATOMA. THE PATIENT WAS PLACED ON DECADRON AND MONITORED IN THE NURSING CARE FACILITY. UPON THE TWO WEEK FOLLOW-UP, THE PATIENT WAS DOING WELL AND HAD REGAINED NORMAL NEUROLOGICAL FUNCTION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THE PHYSICIAN ASSESSED THE HEMATOMA WAS PROCEDURE RELATED AND NOT DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION LEAD IMPLANT PROCEDURE, WITHIN 15 MINUTES OF WAKING UP IN RECOVERY, THE PATIENT WAS UNABLE TO MOVE HER LEGS. A COMPUTED TOMOGRAPHY (CT) MYELOGRAM SCAN REVEALED A HEMATOMA. THE PATIENT WAS PLACED ON DECADRON AND MONITORED IN THE NURSING CARE FACILITY. UPON THE TWO WEEK FOLLOW-UP, THE PATIENT WAS DOING WELL AND HAD REGAINED NORMAL NEUROLOGICAL FUNCTION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THE PHYSICIAN ASSESSED THE HEMATOMA WAS PROCEDURE RELATED AND NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572014 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7082064 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Hospitalization| O| R