BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR? ST

    MDR report key: 22472944 · Received July 10, 2025

    Report

    Report Number
    3006630150-2025-05360
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    August 22, 2024
    Report Date
    September 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI , UPN: M365SC12000 , MODEL: SC-1200 , SERIAL: (B)(6). BATCH: 367079, UDI: (B)(4).

    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: M365SC2317700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7071452, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD A FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A FREQUENT AND DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION, AND THE LEADS HAD HIGH IMPEDANCES. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD A FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809207 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7071285 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention