BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25084083 · Received May 5, 2026

    Report

    Report Number
    3006630150-2026-02894
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 5, 2026
    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
    IN, 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 COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 7093853 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-1416. BATCH/LOT NUMBER: 223290. SERIAL NUMBER: (B)(6) MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA PRIME 16 IPG KIT UNIQUE IDENTIFIER (UDI) #: (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS MIGRATED. THE PATIENT UNDERWENT A LEAD AND IPG EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91384 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7097307 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention