BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18023269 · Received October 27, 2023

    Report

    Report Number
    3006630150-2023-06600
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7082535.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME PAIN. IT WAS NOTED THE PATIENTS INCISION WAS NOT HEALED AND IT APPEARED TO BE INFECTED. THE PATIENT WAS GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS TAKEN BACK INTO SURGERY TO CLEAR UP THE INFECTION AND WAS HOSPITALIZED FOR 3 DAYS TO CONTINUE ANTIBIOTICS AND BE MONITORED. THE CAUSE OF INFECTION STILL UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME PAIN FROM THE PROCEDURE. IT WAS NOTED THE PATIENTS INCISION WAS NOT HEALED AND IT APPEARED TO BE INFECTED. THE PATIENT WAS GIVEN ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131594 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 576161 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H