BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23641519 · Received November 25, 2025

    Report

    Report Number
    3006630150-2025-10785
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: PRODUCT FAMILY: SCS-LINEAR LEADS . UPN: M365SC2218500 . MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7111264/7111260. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2833800 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 547299 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention