BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19556943 · Received June 18, 2024

    Report

    Report Number
    3006630150-2024-03890
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    March 31, 2024
    Report Date
    June 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7081262/7081265.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS MIDLINE INCISION HAS BEEN SLIGHTLY BLEEDING. THE PHYSICIAN BELIEVED THAT IT WAS THE PATIENTS KELOIDS THAT ARE CAUSING THE ISSUE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316423 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 576853 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention