BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 16527124 · Received March 10, 2023

    Report

    Report Number
    3006630150-2023-01208
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    November 5, 2022
    Report Date
    March 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7071944 / 7071973.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444755 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 534179 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention