BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 10548170 · Received September 17, 2020

    Report

    Report Number
    3006630150-2020-04280
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    March 25, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), LOT: 7072019. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), LOT: 5177915. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), LOT: 7072720. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), LOT: 7072801.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AND POOR WOULD HEALING AT THE RIGHT SIDE CRANIAL INCISION SITE. PHYSICIAN ASSESSED THAT THE PATIENT HAD AN INFECTION. CULTURES TAKEN TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS AND CURTIBACTERIUM ACNES. PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE ENTIRE DBS SYSTEM, AND WAS PLACED ON ANTIBIOTICS VIA PICC LINE. POST-OPERATIVELY THE PATIENT SUFFERED ACUTE KIDNEY INJURY AND A HEART BLOCK THAT RESULTED IN THE PLACEMENT OF A PACEMAKER LIKELY DUE TO THE ANTIBIOTICS. PATIENT IS NOW DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014750 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 741319 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention