BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19641265 · Received July 1, 2024

    Report

    Report Number
    3006630150-2024-04213
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7100674/7100613.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOTE ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820663 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 531176 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention