BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17683445 · Received September 5, 2023

    Report

    Report Number
    3006630150-2023-05300
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7093586/7093332.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER AND THE PATIENTS IPG INCISION SITE WAS SWOLLEN, RED AND WAS DRAINING YELLOWISH FLUID. IT WAS ALSO NOTED THAT THE PATIENTS LEAD INCISION SITE WAS SWOLLEN AND TENDER. THE PATIENT WENT TO THE EMERGENCY ROOM AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS HOSPITALIZED AND WAS DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER AND THE PATIENTS IPG INCISION SITE WAS SWOLLEN, RED AND WAS DRAINING YELLOWISH FLUID. IT WAS ALSO NOTED THAT THE PATIENTS LEAD INCISION SITE WAS SWOLLEN AND TENDER. THE PATIENT WENT TO THE EMERGENCY ROOM AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS HOSPITALIZED AND WAS DISCHARGED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD SIGNS OF INFECTION AND WAS PRESCRIBED WITH ANTIBIOTICS. THE PATIENT WAS REPORTEDLY DOING WELL AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167053 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 574911 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention