BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25074991 · Received May 4, 2026

    Report

    Report Number
    3006630150-2026-02872
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    March 20, 2024
    Report Date
    May 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECTS MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7083371, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD PAIN AND SWELLING AT THE POCKET AREA. IT WAS NOTED THAT PATIENT EXPERIENCED BURNING SENSATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE IN THE IPG AND LEAD WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218605 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 581551

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention