BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18865701 · Received March 8, 2024

    Report

    Report Number
    3006630150-2024-01326
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 7, 2024
    Report Date
    March 8, 2024
    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

    EXACT DATE UNKNOWN, EVENT DATE USED WAS THE EXPLANT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH:7031342/5042283.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171118 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 595970 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention