BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23119719 · Received September 23, 2025

    Report

    Report Number
    3006630150-2025-07898
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 29, 2023
    Report Date
    September 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO YEARS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: TWO YEARS AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7051686, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO INADEQUATE STIMULATION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532470 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 523783

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention