BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20390121 · Received October 7, 2024

    Report

    Report Number
    3006630150-2024-06740
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    August 31, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7074814/7074136. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7080843/7080292.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION AT THE NECK INCISION SITE. IT WAS NOTED THAT PATIENT HAD BEEN ON ANTIBIOTICS AND HAD A DEBRIDEMENT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247067 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 757651 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention