BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19199289 · Received April 28, 2024

    Report

    Report Number
    3006630150-2024-02673
    Event Type
    Injury
    Date Received
    April 28, 2024
    Date of Event
    March 13, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7073051/7074183.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING SENSATION AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING SENSATION AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421328 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 511636 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention