BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 10330218 · Received July 27, 2020

    Report

    Report Number
    3006630150-2020-03110
    Event Type
    Injury
    Date Received
    July 27, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7072949, PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7073001. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7073725. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7076050. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT; THEREFORE, THE CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AT THE LEAD INCISION SITE AND SWELLING AT THE IPG POCKET SITE. PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE ENTIRE DBS SYSTEM, AND WAS PLACED ON ANTIBIOTICS. A CULTURE WAS TAKEN, BUT RESULTS WERE NOT PROVIDED. IT IS UNKNOWN WHAT CAUSED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792391 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 741533 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention