BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16309260 · Received February 6, 2023

    Report

    Report Number
    3006630150-2023-00428
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 18, 2023
    Report Date
    March 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(4). BATCH: 7073152.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS DISPOSED AT THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION AT THE IPG SITE. SYMPTOMS OF REDNESS AND SWELLING WERE NOTED. THE PHYSICIAN DID NOT BELIEVE IT WAS DEVICE AND PROCEDURE RELATED AND THE CAUSE OF THE INFECTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135922 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 556293 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention