BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17615186 · Received August 24, 2023

    Report

    Report Number
    3006630150-2023-05025
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7080910, 7081101.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WOUND DEHISCENCE. SYMPTOMS INCLUDE DISCOLORATION, FLUID DISCHARGE, AND REDNESS. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING IMPLANT PAIN. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT SUBSEQUENTLY UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926066 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 552510 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention