BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23013093 · Received September 10, 2025

    Report

    Report Number
    3006630150-2025-07409
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    April 1, 2024
    Report Date
    December 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1232 (SN (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. SC-2218-70 (SN (B)(6)). THE RETURNED LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. SC-2218-70 (SN (B)(6)). THE RETURNED LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. SC-2408-56 (SN (B)(6)). THE RETURNED LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. SC-2408-56 (SN (B)(6)). THE RETURNED LEAD WAS ANALYZED AND WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION REVEALED THAT THE PROXIMAL CONTACT 6 AND 7 ARE DEFORMED AND FLATTENED. DEFORMATION OF THE CONTACTS IS CONSISTENT WITH DAMAGE CAUSED BY USING A SURGICAL TOOL.

    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7094221/7095705, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 3163039/3173289, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CERVICAL PAIN AND THE LEADS CAUSED HEADACHES. THE PATIENT ALSO EXPERIENCED ITCHING AFTER USING THE DEVICE AT HIGH INTENSITY FOR A LONG PERIOD OF TIME. ALL COMPONENTS WERE EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CERVICAL PAIN AND THE LEADS CAUSED HEADACHES. THE PATIENT ALSO EXPERIENCED ITCHING AFTER USING THE DEVICE AT HIGH INTENSITY FOR A LONG PERIOD OF TIME. ALL COMPONENTS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048230 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 576672 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention