BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24811399 · Received April 7, 2026

    Report

    Report Number
    3006630150-2026-02147
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: O MODEL NUMBER/CATALOG NUMBER: SC-1216 O SERIAL NUMBER: (B)(6). O BATCH/LOT NUMBER: 587695 O MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 16 IPG KIT O UNIQUE IDENTIFIER (UDI) # (B)(4). O MODEL NUMBER/CATALOG NUMBER: SC-2218-50 O SERIAL NUMBER: (B)(6). O BATCH/LOT NUMBER: 7133857 O MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM O UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT REPLACEMENT OF BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE PERCUTANEOUS LEADS. THE EXISTING BATTERY WAS REPLACED, BUT THE REASON FOR THIS INTERVENTION WAS NOT SPECIFIED. THE PERCUTANEOUS LEADS WERE REPLACED DUE TO ANTERIOR MALPOSITION AND INCORRECT POSITIONING, AND A PADDLE LEAD WAS IMPLANTED INSTEAD. THE LOCATION OF THE DEVICES IS UNKNOWN. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438474 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7133256 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1