BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14703853 · Received June 15, 2022

    Report

    Report Number
    3006630150-2022-02909
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    April 23, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A MONTH AGO FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEAD; UPN: M365SC8336700; MODEL: SC-8336-70; SERIAL: (B)(4); BATCH: 7071414.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT THE IMPLANT SITE WAS SEEPING WHICH WAS CONFIRMED BY THE PHYSICIAN AND THAT THE SITE WAS BLISTERED DUE TO THE POSITIONING OF THE DEVICE AT HIS BELT LINE. THE PATIENT UNDERWENT AN IPG AND LEAD EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE NOT RETURNED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313497 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 519959 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention