BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16711363 · Received April 11, 2023

    Report

    Report Number
    3006630150-2023-01912
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    March 4, 2023
    Report Date
    April 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7076736 / 7080006 / 7080026 / 7080045. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7071658 / 7072911.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE ON THE NECK. SYMPTOMS OF PAIN AND SWELLING WERE NOTED. THE PATIENTS INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS REMOVED. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862118 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 516274 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention