BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17414035 · Received July 28, 2023

    Report

    Report Number
    3006630150-2023-04410
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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-PADDLE LEADS, UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(6), BATCH: 7070266.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG DID NOT COVER THE PAIN AREAS DESPITE SEVERAL REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IPG AND PADDLE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337245 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 529443 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention