BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16856701 · Received May 2, 2023

    Report

    Report Number
    3006630150-2023-02424
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    March 18, 2023
    Report Date
    June 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7120244/7120817.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD LOCALIZED INFECTION AT THE POCKET SITE. SYMPTOMS OF REDNESS, TENDERNESS AND DRAINAGE DESCRIBE AS BLOODY AND YELLOW WERE NOTED. IT WAS ALSO MENTIONED THAT THE PATIENT DID NOT GET MUCH RELIEF. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD LOCALIZED INFECTION AT THE POCKET SITE. SYMPTOMS OF REDNESS, TENDERNESS AND DRAINAGE DESCRIBE AS BLOODY AND YELLOW WERE NOTED. IT WAS ALSO MENTIONED THAT THE PATIENT DID NOT GET MUCH RELIEF. THE PATIENT WILL UNDERGO A REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT SCS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICE WAS NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258682 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 562688 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention