BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 18822284 · Received March 1, 2024

    Report

    Report Number
    3006630150-2024-01123
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7072237.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED STAPHYLOCOCCUS AUREUS INFECTION IN THE LOWER BACK. SYMPTOMS OF RED AND PUFFY SITE WERE NOTED. THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT A FULL EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237255 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 525079 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention