BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR? ST

    MDR report key: 18667673 · Received February 8, 2024

    Report

    Report Number
    3006630150-2024-00545
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 11, 2024
    Report Date
    April 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2408740, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7103095.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7103856, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(6), BATCH: 542268, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEAD HAD HIGH IMPEDANCES. IT WAS NOTED THAT THE PATIENTS LEADS IS SUSPECTED OF FRACTURE. THE PATIENT WILL UNDERGO REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A REVISION PROCEDURE AT THIS TIME DUE TO OTHER HEALTH CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEAD HAD HIGH IMPEDANCES. IT WAS NOTED THAT THE PATIENTS LEADS IS SUSPECTED OF FRACTURE. THE PATIENT WILL UNDERGO REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEAD HAD HIGH IMPEDANCES. IT WAS NOTED THAT THE PATIENTS LEADS IS SUSPECTED OF FRACTURE. THE PATIENT WILL UNDERGO REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A REVISION PROCEDURE AT THIS TIME DUE TO OTHER HEALTH CONCERNS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765498 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7103095

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention