BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25128133 · Received May 8, 2026

    Report

    Report Number
    3006630150-2026-02992
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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)(6). BATCH/LOT NUMBER: 7101825 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #:(B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7102644 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200801 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 776474 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1