BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16533975 · Received March 13, 2023

    Report

    Report Number
    3006630150-2023-01230
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    June 10, 2022
    Report Date
    March 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AFTER THE IMPLANT DATE. 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:7073219/7073226; PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, BATCH: 26656888.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO STATED THAT THE PATIENTS IPG WAS NO LONGER WORKING AS INTENDED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036693 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 510052 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention