BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 12096996 · Received June 30, 2021

    Report

    Report Number
    3006630150-2021-03376
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7072371. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7072369.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IN THE CLINICAL STUDY FOR DEPRESSION EXPERIENCED ABDOMINAL PAIN SIX DAYS AFTER A DBS DEEP BRAIN STIMULATOR IMPLANT PROCEDURE. THE LABORATORY EVALUATION REVEALED ELEVATED D-DIMERS AND THE CONTRAST ENHANCED COMPUTED TOMOGRAPHY CT SCAN REVEALED A PULMONARY EMBOLISM PE. COMPRESSION STOCKINGS AND ANTITHROMBOTIC PHARMACOLOGY HAD BEEN ADMINISTERED AS ANTITHROMBOTIC MEASURES TAKEN PRIOR TO THE PROCEDURE AS THIS PATIENT HAD EXPERIENCED A PRIOR PE. FOLLOWING THE PROCEDURE, THE PATIENT WAS ADMINISTERED THE ANTICOAGULANT HEPARIN AND IS IN STABLE CONDITION. IT WAS NOTED THAT PRIOR TO THE PROCEDURE, THE PATIENT SPENT AN UNUSUAL AMOUNT OF TIME INACTIVE IN OR ON HIS BED, DUE TO DEPRESSION. THE PHYSICIAN EVALUATED THAT THE PE WAS NOT DUE TO THE MEDICAL DEVICE OR TO AN INCREASED PROPENSITY OF THE CLINICAL STUDY EXPERIMENT. THE PHYSICIAN ASSESSED THAT THE PE WAS RELATED TO THE SURGICAL PROCEDURE AN NOTED THAT A PULMONARY EMBOLISM CAN BE A RISK OF ANY SURGICAL OR ANESTHETIC INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986983 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 744665

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention