BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20868410 · Received December 6, 2024

    Report

    Report Number
    3006630150-2024-08509
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 9, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 WEEKS AFTER IMPLANT. BLOCK D6B: EXPLANT DATE: 3 WEEKS AFTER IMPLANT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7082284.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF INFECTION WAS AT THE SPINAL CORD STIMULATION (SCS) LEAD SITE. IT WAS NOTED THAT THE PATIENT WAS TREATED FOR DISKITIS AND OSTEOMYELITIS. SYMPTOMS WERE WORSENING PAIN AND SUPERFICIAL SOFT TISSUE SWELLING AT THE LEAD SITE. THE INFECTION WAS NOT PROCEDURE RELATED. ANTIBIOTICS WERE PRESCRIBED. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468013 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 575611 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention