BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15758514 · Received November 9, 2022

    Report

    Report Number
    3006630150-2022-06102
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    October 7, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED AFTER THE IMPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7112530/7112538.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SOME INFLAMMATION AND ITCHING AT THE IPG AND LEAD INCISION SITES DUE TO POSSIBLE INFECTION OR A REACTION FROM THE ADHESIVE. THE INFECTION WAS NOT CONFIRMED. THE PATIENT WAS GIVEN AN ANTI-MICROBIAL DRESSING OVER THE TWO AREAS AND WAS CONTINUING TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2947721 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 550730 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention