BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19757845 · Received July 16, 2024

    Report

    Report Number
    3006630150-2024-04602
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(6) BATCH: 7080040.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION ON BOTH INCISION SITES. FLUID BUILDUP WAS NOTED ON BOTH SITES. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT UNDERWENT EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS RETAINED AT THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504509 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 590915 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention