BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16278923 · Received February 1, 2023

    Report

    Report Number
    3006630150-2023-00324
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    December 8, 2022
    Report Date
    March 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7076176. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7076980.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED AN EPILEPTIC SEIZURE, WHICH WAS ASSESSED AS BEING MILD IN SEVERITY. THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS HAVING A POSSIBLE RELATIONSHIP TO THE PROCEDURE, BUT THE RELATIONSHIP TO THE DEVICE WAS REPORTED AS NOT RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED AN EPILEPTIC SEIZURE, WHICH WAS ASSESSED AS BEING MILD IN SEVERITY. THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS HAVING A POSSIBLE RELATIONSHIP TO THE PROCEDURE, BUT THE RELATIONSHIP TO THE DEVICE WAS REPORTED AS NOT RELATED. ADDITIONAL INFORMATION WAS RECEIVED THAT COMPLICATIONS SUCH AS A BLEED OR FRESH ISCHEMIA, CEREBROSPINAL FLUID CIRCULATION DISORDER, AND SIGNS OF HERNIATION WERE EXCLUDED THROUGH A CRANIAL COMPUTED TOMOGRAPHY (CT) SCAN AND CHEST X-RAY. THE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS ALSO IN REGULAR POSITION. AN ADDITIONAL THERAPY WITH LEVETIRACETAM WAS INITIATED TO TREAT THE PATIENT. NO NEW ABNORMALITIES IN THE SENSE OF AN EPILEPTIC EVENT WERE RECORDED OVER THE SHORT-TERM COURSE OF INPATIENT TREATMENT. THE LAB TESTS REVEALED A VALPROIC ACID LEVEL BELOW THE THERAPEUTIC LIMIT, FOR WHICH REASON THE PATIENTS DOSE OF MEDICATION WAS INCREASED. THE PHYSICIAN DEESCALATED LEVETIRACETAM WITH THE GOAL OF ESTABLISHING MONOTHERAPY AGAIN OVER TIME. DUE TO THE PATIENTS REPORTED DEPRESSED MOOD DUE TO THE DISEASE AND THE MOOD-STABILIZING EFFECT OF VALPROIC ACID, THE PHYSICIAN DID NOT RECOMMEND DISCONTINUING OR SUBSTITUTING THE PATIENTS MEDICATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346979 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 525647 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other