BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23402388 · Received October 28, 2025

    Report

    Report Number
    3006630150-2025-09649
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: M365SC8436500 MODEL: SC-8436-50 SERIAL: (B)(6) BATCH: 7090816 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON BOTH INCISION SITES FOLLOWING AN IMPLANT PROCEDURE. SYMPTOMS OF FLUID DISCHARGE AND REDNESS WERE NOTED. THE PATIENT PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED AND THE CAUSED WERE UNKNOWN HOWEVER, DIRECTLY RELATED TO THE INCISION SITE. THE PATIENT WAS SENT TO THE HOSPITAL AND HAD A PROCEDURE WHEREIN THE IPG AND PADDLE LEAD WERE EXPLANTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352205 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 794508 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention