BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11340904 · Received February 17, 2021

    Report

    Report Number
    3006630150-2021-00534
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    October 31, 2020
    Report Date
    April 1, 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ADJUSTMENT DISORDER DUE TO SEVERE AGGRAVATED MULTIMORBIDITY. THE PATIENT WAS ADMITTED AND UNDERWENT ILEUS SURGERY AND PSYCHIATRIC EVALUATION. THE PHYSICIAN ASSESSED THE EVENT AS UNLIKELY RELATED TO THE DEVICE HARDWARE, AND NOT RELATED TO THE PROCEDURE OR STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ADJUSTMENT DISORDER DUE TO SEVERE AGGRAVATED MULTIMORBIDITY. THE PATIENT WAS ADMITTED AND UNDERWENT ILEUS SURGERY AND PSYCHIATRIC EVALUATION. THE PHYSICIAN ASSESSED THE EVENT AS UNLIKELY RELATED TO THE DEVICE HARDWARE, AND NOT RELATED TO THE PROCEDURE OR STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT UNDERGO ILEUS SURGERY AND PSYCHIATRIC EVALUATION. HOWEVER, THE PATIENT SHOWED SYMPTOMS OF HYPERKINESIA, SEVER HYPERMOBILITY WITH SIMULTANEOUS BILATERAL INCREASE IN TONE AND LACK OF ABILITY TO SPEAK. THE PATIENT STIMULATION AND MEDICATIONS WERE ADJUSTED, AND THE PHYSICIAN ASSESSED THE EXTREME FLUCTUATION IN SYMPTOMS WERE EXPLAINED IN THE CONTEXT OF A FUNCTIONAL ETIOLOGY AND NO CONNECTION TO CURRENT THERAPY COULD BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5162683. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5162686.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ADJUSTMENT DISORDER DUE TO SEVERE AGGRAVATED MULTIMORBIDITY. THE PATIENT WAS ADMITTED AND UNDERWENT ILEUS SURGERY AND PSYCHIATRIC EVALUATION. THE PHYSICIAN ASSESSED THE EVENT AS UNLIKELY RELATED TO THE DEVICE HARDWARE, AND NOT RELATED TO THE PROCEDURE OR STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236653 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 743735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention