BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16826242 · Received April 27, 2023

    Report

    Report Number
    3006630150-2023-02323
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    December 17, 2023
    Report Date
    April 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS AGO FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7040039 / 7041641; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2208500, MODEL: SC-2208-50, SERIAL: (B)(4), BATCH: 182597 / 182637.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND OVERSTIMULATION WITH THE DEVICE. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED FROM THE RIGHT ABDOMEN TO THE RIGHT FLANK AND THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED AS IT WAS DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559161 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 549391 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention