BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19176605 · Received April 24, 2024

    Report

    Report Number
    3006630150-2024-02602
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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: 7120533/7116797.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. IT WAS NOTED ALSO THAT PATIENT HAS BEEN EXPERIENCING LEG WEAKNESS AND WAS TOLD THAT IT COULD BE RELATED TO THE DEVICE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED AND EXPLANTED DEVICES WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155093 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 566183 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention