BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18728181 · Received February 17, 2024

    Report

    Report Number
    3006630150-2024-00773
    Event Type
    Injury
    Date Received
    February 17, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7080815/7080818.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION IN AN UNKNOWN LOCATION. SYMPTOMS OF FULL BODY PAIN AND FATIGUE WERE NOTED. PHYSICIAN BELIEVED THAT THE INFECTION WAS RELATED TO THE DEVICE. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425381 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 575963 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention