BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16689195 · Received April 6, 2023

    Report

    Report Number
    3006630150-2023-01822
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4). BATCH: 7080673/7080661.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT AROUND THE IPG SITE. IT WAS NOTED ALSO THAT THE PATIENTS LEADS HAD MIGRATED AND WAS NOT ABLE TO FEEL ENOUGH COVERAGE. THE PATIENT UNDERWENT AN IPG REPOSITIONING AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISPOSED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912547 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 557609 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention