BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17887872 · Received October 6, 2023

    Report

    Report Number
    3006630150-2023-06084
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8436500, MODEL: SC-8436-50, SERIAL: (B)(6), LOT: 7083002.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A SEVERE INFECTION OF THE DEEP INCISIONAL SURGICAL SITE. SYMPTOMS INCLUDED FEVER, CHILLS, AND A RAPID HEART RATE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR AND LEAD WERE EXPLANTED. THE EVENT WAS ASSESSED TO BE RELATED TO THE IMPLANT PROCEDURE AND HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307245 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 579878 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention