BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17892433 · Received October 6, 2023

    Report

    Report Number
    3006630150-2023-06104
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 10, 2023
    Report Date
    October 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7090286/7092259.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. SYMPTOMS OF SWELLING, REDNESS AND PUS WERE NOTED. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT PROCEDURE RELATED AND NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PRESCRIBED ANTIBIOTICS. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020864 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 573138 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention