BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19411495 · Received May 28, 2024

    Report

    Report Number
    3006630150-2024-03445
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7080620.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED VIA FACILITY MEDWATCH FORM MW5154045, THAT PATIENT HAD INCREASED PAIN IN MORE LOCATIONS. IT WAS NOTED THAT PATIENT HAD A METAL ALLERGY WHICH RESULTED IN SEVERE ITCHING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED VIA FACILITY MEDWATCH FORM MW5154045, THAT PATIENT HAD INCREASED PAIN IN MORE LOCATIONS. IT WAS NOTED THAT PATIENT HAD A METAL ALLERGY WHICH RESULTED IN SEVERE ITCHING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT ALL DEVICES WERE EXPLANTED AND WILL NOT BE RETURN DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585333 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 558822 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention