BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 20776941 · Received November 26, 2024

    Report

    Report Number
    3006630150-2024-08130
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 26, 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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT BRAND NAME: LINEAR 3-4, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7073339. BRAND NAME: LINEAR 3-4, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7073333.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCIATICA PAIN. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PATIENT WAS HOSPITALIZED AND THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND SHE IS RECOVERING FROM HOME. THE PHYSICIAN COULD NOT CONFIRM WHETHER THE SCS SYSTEM WAS THE CAUSE OF PATIENTS SCIATICA, HOWEVER THE SYMPTOMS SEEM TO BE EASING NOW THAT IT HAS BEEN EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414494 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 535291 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1