BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17159489 · Received June 19, 2023

    Report

    Report Number
    3006630150-2023-03493
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    May 31, 2023
    Report Date
    June 19, 2023
    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

    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: 7080556.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION AT THE IPG SITE. SYMPTOMS OF REDNESS, OOZING AT INCISION SITE, FEVER AND CHILLS WERE NOTED. INFECTION WAS NOT PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987338 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 557703 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention