BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19815482 · Received July 24, 2024

    Report

    Report Number
    3006630150-2024-04792
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7139579/7141482.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT GOT NO BENEFITS WITH THE DEVICE AND MADE HER PAIN WORSE. THE PATIENT HAD DIFFICULTY CHARGING THE IPG. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343174 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 593072 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention