BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 12105594 · Received July 2, 2021

    Report

    Report Number
    3006630150-2021-03425
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    April 9, 2020
    Report Date
    August 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 5076164. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 5142620.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF INFECTION OF HIS DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PHYSICIAN DETERMINED THAT THE ENTIRE DBS SYSTEM NEEDED TO BE EXPLANTED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM THAT SAME DAY AND THE ENTIRE DBS SYSTEM WAS EXPLANTED. NO PRODUCTS WERE IMPLANTED. THE EXPLANTED PRODUCT WAS SENT FOR CULTURE AND WILL BE DISPOSED OF BY THE HOSPITAL. THE PATIENT HAS BEEN GIVEN THEIR ANTIBIOTIC PROTOCOL FOR POTENTIAL INFECTION AND THEY PLAN TO RE-EVALUATE IN 3 MONTHS FOR POTENTIAL RE-IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE ON THE POSTOP CARE OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF INFECTION OF HIS DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PHYSICIAN DETERMINED THAT THE ENTIRE DBS SYSTEM NEEDED TO BE EXPLANTED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM THAT SAME DAY AND THE ENTIRE DBS SYSTEM WAS EXPLANTED. THE EXPLANTED PRODUCT WAS SENT FOR CULTURE AND WILL BE DISPOSED OF BY THE HOSPITAL. THE PATIENT HAS BEEN GIVEN THEIR ANTIBIOTIC PROTOCOL FOR POTENTIAL INFECTION AND THEY PLAN TO RE-EVALUATE IN 3 MONTHS FOR POTENTIAL RE-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008804 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 738376 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention