BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24790311 · Received April 6, 2026

    Report

    Report Number
    3006630150-2026-02088
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 15, 2023
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE DEVICES WERE 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 ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408740 MODEL: SC-2408-74 SERIAL: (B)(6). BATCH: 7073567 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408740 MODEL: SC-2408-74 SERIAL: (B)(6). BATCH: 7073891 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO INADEQUATE THERAPY RELIEF. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO INADEQUATE THERAPY RELIEF. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430239 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 534682 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1