BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23727729 · Received December 5, 2025

    Report

    Report Number
    3006630150-2025-11218
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 12, 2022
    Report Date
    December 5, 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
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE YEARS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7110257 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FEELING STIMULATION STRONGLY AND PAINFULLY EVEN AFTER LETTING THE IMPLANTABLE PULSE GENERATOR (IPG) DISCHARGE COMPLETELY AND THE REMOTE CONTROL WOULD NOT CONNECT. IT WAS ALSO NOTED THAT THE PATIENT WAS FEELING STIMULATION IN A NON-TARGET AREA AND STIMULATION WAS NO LONGER ADEQUATE. IT WAS FURTHER MENTIONED THAT THE PATIENT WAS EXPERIENCING WEIRD ELECTRICAL PULSES IN THE UPPER BACK ABOVE THE SPINAL CORD STIMULATOR (SCS) LEADS AND IPG AND HAD AN ALLERGY TO LATEX OR PLASTICS. THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850893 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 551817 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R