BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12705500 · Received October 27, 2021

    Report

    Report Number
    3006630150-2021-06025
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    June 23, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED ON (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS- LINEAR LEADS: UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7073025/7073231.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS MIDLINE INCISION BY LEAD ENTRY SITE WAS NOT HEALING CORRECTLY WITH CONSTANT DRAINAGE, AND WAS BEING MONITORED FOR SIGNS OF INFECTION. IT WAS UNKNOWN IF IT WAS DEVICE RELATED BUT WAS NOTED THAT THE PATIENT FELT OFF BALANCE AND LOST CONTROL OF THE LEGS. THE PATIENT WAS PLACED ON ANTIBIOTICS NUMEROUS TIMES, AND UNDERWENT AN EXPLANT PROCEDURE FOR THE WHOLE SYSTEM. THE EXPLANTED IPG AND PERCUTANEOUS LEADS WERE SENT FOR CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603015 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 512370 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention