BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15597260 · Received October 13, 2022

    Report

    Report Number
    3006630150-2022-05517
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(4). BATCH: 7072827.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO (ER) EMERGENCY ROOM DUE TO AN INFECTION AT THE IPG AND LEAD INCISION SITE. SYMPTOMS OF FEVER, SWELLING, REDNESS AND FLUID DISCHARGE WERE NOTED. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842976 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 545635 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention