BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16196489 · Received January 18, 2023

    Report

    Report Number
    3006630150-2023-00109
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT DATE USED WAS THE DATE OF EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 7073623/7073621/7073615/7073582.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOMS OF FEVER, CHILLS AND COUGH WERE NOTED. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE NOR PROCEDURE RELATED, HOWEVER PHYSICIAN THOUGHT THAT THE INFECTION WAS CAUSED BY THE PATIENT PICKING AT HER IPG INCISION SITE. THE PATIENT WAS PLACE ON ANTIBIOTICS AND NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 549597 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention