BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24175984 · Received January 26, 2026

    Report

    Report Number
    3006630150-2026-00501
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    December 18, 2024
    Report Date
    April 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A WEEK THE IMPLANT DATE.

    Additional Manufacturer Narrative · 0

    SC-1232 (SN (B)(6) / SC-2218-70 (SN (B)(6). INVESTIGATION RESULTS, MEDIA REVIEW, DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7103956 / 7090273 / 7102006 / 7103786, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION AND INADEQUATE STIMULATION. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION AND INADEQUATE STIMULATION. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION AND INADEQUATE STIMULATION. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346810 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 769137 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1