BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15974578 · Received December 13, 2022

    Report

    Report Number
    3006630150-2022-06981
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    August 1, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8336700; MODEL: SC-8336-70; SERIAL: (B)(4); BATCH: 7070839.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WOULD HAVE HEADACHES WHEN USING THE STIMULATOR. REPROGRAMMING HELPED AND THE HEADACHES WERE INTERMITTENT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE STILL DUE TO THE HEADACHES. ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474416 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 536451 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention