BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16563325 · Received March 17, 2023

    Report

    Report Number
    3006630150-2023-01330
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7072889.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS PROTRUDING. IT WAS NOTED ALSO THAT PATIENT HAD LOSS SIGNIFICANT WEIGHT AND HAD OTHER MEDICAL CONDITION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WERE ALL DEVICE WAS REMOVED. THE EXPLANTED DEVICE WAS DISCARDED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546931 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 529519 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention