BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18053095 · Received November 2, 2023

    Report

    Report Number
    3006630150-2023-06725
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    July 25, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER THE PAST SEVERAL WEEKS FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7123308/7129608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THROUGH AN X RAY. HIGH IMPEDANCES WERE ALSO NOTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A PADDLE LEAD WAS IMPLANTED. THERE WAS NO DEVICE MALFUNCTION SUSPECTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928642 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7122786 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention