BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18720848 · Received February 16, 2024

    Report

    Report Number
    3006630150-2024-00736
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EXPLANT DATE USED AS THE APPROXIMATED DATE OF EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: M365SC8436500 MODEL: SC-8436-50 SERIAL: (B)(6) BATCH: 7081778

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO STIMULATION CAUSING DISCOMFORT. ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529856 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 569364 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention