BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17359713 · Received July 20, 2023

    Report

    Report Number
    3006630150-2023-04258
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 30, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(6) , BATCH: 7073029.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE AND PUSS WAS COMING OUT OF THE IPG INCISION. IT WAS UNKNOWN IF IT WAS DEVICE RELATED AS THE PATIENT DID NOT FOLLOW PROTOCOL KEEPING THE INCISION CLEAN. THE PHYSICIAN NOTED THAT THE REVISION WILL NOT HAPPEN SINCE THE PATIENT WAS GIVEN ANTIBIOTICS AND ALL SCANS INDICATED THAT THE INFECTION WAS CLEARING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109566 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 564891 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention