BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17825444 · Received September 27, 2023

    Report

    Report Number
    3006630150-2023-05881
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 27, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI; UPN: M365SC8416700; MODEL: SC-8416-70; SERIAL: (B)(6); BATCH: 7070996.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS HAD AN INFECTION AT THE IPG AND LEAD SITE. THE SYMPTOMS WERE PAIN AND YELLOW PUS. IT WAS NOTED THAT THE IPG SITE WAS SLIGHTLY OPENED, AND THE PATIENT WAS TOLD THAT THERE WAS A SEED TICK DURING THE SURGERY WHICH LED TO INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS GIVEN ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097933 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 568940 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention