BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20433510 · Received October 11, 2024

    Report

    Report Number
    3006630150-2024-06880
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336700 MODEL: SC-8336-70 SERIAL: (B)(6) BATCH: 7072300.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TINGLING EVEN THOUGH STIMULATION WAS TURNED OFF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE, AND THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313121 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 539353 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention