BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24824423 · Received April 8, 2026

    Report

    Report Number
    3006630150-2026-02176
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    January 1, 2023
    Report Date
    April 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED AROUND THE YEAR OF 2023. BLOCK D6B: EXPLANT DATE: AROUND THE YEAR OF 2023 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7073296 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). NUMBER/CATALOG NUMBER: SC-2352-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7073146 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873243 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 508981 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention