BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17696939 · Received September 7, 2023

    Report

    Report Number
    3006630150-2023-05378
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    December 22, 2021
    Report Date
    September 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7082132/7082370.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN INCREASED PAIN. ALL DEVICE COMPONENTS WERE EXPLANTED AND DISCARDED BY THE MEDICAL FACILITY. THERE WAS NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293633 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 528904 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention