BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 10525764 · Received September 11, 2020

    Report

    Report Number
    3006630150-2020-04158
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICES: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7071979. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7074363. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7073043. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7073237.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGING WAS PERFORMED WHICH LED THE PHYSICIAN TO BELIEVE THAT AN INFECTION WAS PRESENT. IN ADDITION, THERE WAS SUPERFICIAL REDNESS, AN OPEN SORE AND SOME DRAINAGE AT THE INCISION SITE ABOVE LEAD EXTENSIONS. THE PHYSICIAN SUSPECTED AN INTRA-CRANIAL INFECTION AND EXPLANTED THE ENTIRE SYSTEM. IN ADDITION THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN DOES NOT FEEL THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. A CULTURE WAS PERFORMED HOWEVER THE RESULTS WILL NOT BE PROVIDED. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988952 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 742338 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention