BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 14164446 · Received April 20, 2022

    Report

    Report Number
    3006630150-2022-01772
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7085789. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7087504. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 24669210. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 24669136. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 28009699. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 5178307. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7072605.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEEP BRAIN STIMULATION (DBS) EXPLANT PROCEDURE DUE TO AN INFECTION. THE INFECTION WAS LOCATED BEHIND THE LEFT EAR, ON THE SAME SIDE AS THE LEAD EXTENSIONS AND IMPLANTABLE PULSE GENERATOR (IPG) . THE ENTIRE SYSTEM WAS REMOVED HOWEVER, THE PHYSICIAN ASSESSED THAT THE INFECTION WAS NOT DEVICE-RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL POST-OPERATIVELY. A CULTURE OF THE INFECTION SITE WAS NOT TAKEN. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DESTROYED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920213 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 741146 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention