BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19646114 · Received July 1, 2024

    Report

    Report Number
    3006630150-2024-04225
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    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: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7143731/7144191.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEMONSTRATED SEVERE ANXIETY FOLLOWING THE IMPLANT PROCEDURE. THE PHYSICIAN NOTED THAT THE PATIENT REPEATEDLY PRESENTED IN THE CLINIC REQUESTING TO HAVE THE DEVICE REMOVED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571346 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 755758 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention