BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 4244059 · Received November 11, 2014

    Report

    Report Number
    3006630150-2014-02576
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: DB-2201-45BC, SERIAL #: (B)(4), DESCRIPTION: VERCISE LEAD KIT, 45CM. MODEL #: NM-3138-55, SERIAL #: (B)(4), DESCRIPTION: 55 CM 8 CONTACT EXTENSION KIT.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE REPORTED IN THIS MDR FORM FALLS UNDER INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A PRE-EXISTING CHEST INFECTION PRIOR TO THE IMPLANT PROCEDURE. THE INFECTION WAS EXACERBATED DUE TO THE IMPLANT PROCEDURE. THE PATIENT WAS ALREADY HOSPITALIZED DUE TO THE INFECTION AND REMAINS UNWELL BUT STABLE IN THE ICU AND HAS BEEN ADMINISTERED IV ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A PRE-EXISTING CHEST INFECTION PRIOR TO THE IMPLANT PROCEDURE. THE INFECTION WAS EXACERBATED DUE TO THE IMPLANT PROCEDURE. THE PATIENT WAS ALREADY HOSPITALIZED DUE TO THE INFECTION AND REMAINS UNWELL BUT STABLE IN THE ICU AND HAS BEEN ADMINISTERED IV ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A PRE-EXISTING CHEST INFECTION PRIOR TO THE IMPLANT PROCEDURE. THE INFECTION WAS EXACERBATED DUE TO THE IMPLANT PROCEDURE. THE PATIENT WAS ALREADY HOSPITALIZED DUE TO THE INFECTION AND REMAINS UNWELL BUT STABLE IN THE ICU AND HAS BEEN ADMINISTERED IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726757 VERCISE DEEP BRAIN STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION DB-1110-C N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R