BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20659701 · Received November 11, 2024

    Report

    Report Number
    3006630150-2024-07752
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    April 1, 2022
    Report Date
    December 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APRIL 2022 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: 7077156/ 7082925/ 7079425.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAVE PULLED COMPLETELY OUT OF THE EPIDURAL SPACE. X-RAY REVEALED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE LEADS WERE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS IMPLANTED WITH MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE LEADS AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAVE PULLED COMPLETELY OUT OF THE EPIDURAL SPACE. X-RAY REVEALED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644300 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7082891 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention