BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14517827 · Received May 26, 2022

    Report

    Report Number
    3006630150-2022-02521
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 7072768.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF NEURALGIA AROUND PATIENTS RIB AND BREAST AREA. IT WAS ALSO NOTED THAT THE PADDLE LEAD THAT HAD SLIGHTLY OFF TO ONE SIDE DUE TO PATIENTS NON-DEVICE RELATED CONDITION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763423 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 523946 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention