BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR? ST

    MDR report key: 24851368 · Received April 11, 2026

    Report

    Report Number
    3006630150-2026-02264
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7111267. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD FRACTURED CONTACTS. IT WAS NOTED THAT THE PATIENT SUFFERED A FALL THAT MAY HAVE IMPACTED THE SPINAL CORD STIMULATOR (SCS) LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239891 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7109642 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female