BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22616876 · Received July 25, 2025

    Report

    Report Number
    3006630150-2025-05891
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    November 12, 2024
    Report Date
    July 25, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7082041, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7082223, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 33778734, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PERSISTENT PAIN AND HYPERSENSITIVITY AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND ANCHOR SITES. THE PATIENT WAS ADMINISTERED WITH PAIN MEDICATIONS WHICH DID NOT PROVIDE RELIEF, AND THE PATIENT WAS THEN PUT ON TIZANIDINE AS A MUSCLE RELAXANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175282 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 756080 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention