BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16943210 · Received May 16, 2023

    Report

    Report Number
    3006630150-2023-02780
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 10, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45-DC, SERIAL: (B)(6), BATCH: 7073101 AND 7073116. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 30042542. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3128950, MODEL: DB-3128-95, SERIAL: (B)(6), BATCH: 5000563.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WITH SWELLING ON THE RIGHT SIDE OF HER HEAD AT THE LEAD AND LEAD EXTENSION CONNECTION SITE. THE PATIENT REPORTED FEELING TIGHTNESS ON THE RIGHT SIDE OF HER NECK. WHILE IN THE ER THE PATIENTS' SWELLING AT THE LEAD AND LEAD EXTENSION SITE DEVELOPED INTO AN ABSCESS. REDNESS AND SWELLING WERE ALSO NOTED AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION CONNECTION SITE ON HER CHEST. THE FOLLOWING DAY THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT. THE PHYSICIAN NOTED MINIMAL SIGNS OF INFECTION AT THE LEAD AND BURR HOLE COVER SITE, LEAD AND LEAD EXTENSION SITE, AND THE IPG SITE. THE CAUSE OF THE INFECTION IS UNKNOWN, HOWEVER THE PHYSICIAN NOTED THAT DURING THE STAGE TWO IMPLANT OF THE IPG A HEMATOMA DEVELOPED AT THE IPG SITE WHICH MAY HAVE CAUSED THE INFECTION. CULTURES WERE TAKE AT THE THREE INFECTION SITES, BUT THE RESULTS ARE NOT AVAILABLE. THE PATIENT SPENT THE NIGHT IN THE HOSPITAL AND PRESCRIBED ANTIBIOTICS, AND HAS BEEN DISCHARGED. PER THE FACILITY'S POLICY THE DEVICES WERE NOT RELEASED, THEREFORE NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695854 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 560463 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H