BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21223786 · Received January 23, 2025

    Report

    Report Number
    3006630150-2025-00165
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    March 12, 2024
    Report Date
    May 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7077267/7075713. THIS REPORT IS BEING SUBMITTED TO CORRECT THE E1.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7077267/7075713.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THERE WAS LEAD MIGRATION. THE PATIENT UNDERWENT REVISION PROCEDURE. PATIENT IS FINE. HOSPITAL KEPT IMPLANTABLE PULSE GENERATOR (IPG) AND ARTISAN LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THERE WAS LEAD MIGRATION. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATION (SCS) LEADS WERE REPLACED. A NEW PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445589 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 589556

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention