BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 8034772 · Received November 2, 2018

    Report

    Report Number
    3006630150-2018-61634
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    October 8, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANT DATE: N/A; DEVICE REMAINS IMPLANTED AND IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EDEMA WAS REABSORBED AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS (DB-2202-30, SERIAL NUMBER: (B)(4)) REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS (DB-2202-30, SERIAL NUMBER: (B)(4)) REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. ANALYSIS OF THE LEAD (DB-2202-30 / SERIAL NUMBER: 5011357) REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION, THE DEVICE-TO-DEVICE INTERACTION TEST, AND THE DIMENSION TEST AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A VERY SHARP EDEMA ON THE LEFT SIDE OF THE BRAIN THE DAY AFTER A LEAD REPLACEMENT PROCEDURE. THE ONLY MEDICAL INTERVENTION THAT WAS PROVIDED AFTER THE LEAD REPLACEMENT WAS CORTISONE THERAPY. THE PHYSICIAN NOTED THAT BOTH LEADS WERE AFFECTED BY EDEMA, BUT IT IS CLEARLY LARGER ON THE LEFT SIDE, WHERE THE LEAD REPLACEMENT PROCEDURE TOOK PLACE. THE PHYSICIAN STATED THAT THE EDEMA EXTENDS THE ENTIRE LENGTH OF THE LEAD, EXPANDING TOWARD THE FRONTAL REGION. THE EDEMA WAS ALSO SYMPTOMATIC, WITH EVIDENT CONFUSION AND SEVERE SPATIO-TEMPORAL DISORIENTATION. PATIENT IS GETTING BETTER WITH THE CONFUSIONAL STATE BEING ALMOST FINISHED AND THE EDEMA HAS GRADUALLY BEEN ADSORBED. A FOLLOW-UP TEST IS PLANNED FOR THE NEXT FEW DAYS WITH A GRADUAL REDUCTION OF THE CORTISONE THERAPY AND CONSEQUENT ACTIVATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-2202-30. SERIAL/LOT: (B)(4). DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 30 CM. MODEL: DB-2202-30. SERIAL/LOT: (B)(4). DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 30 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A VERY SHARP EDEMA ON THE LEFT SIDE OF THE BRAIN THE DAY AFTER A LEAD REPLACEMENT PROCEDURE. THE ONLY MEDICAL INTERVENTION THAT WAS PROVIDED AFTER THE LEAD REPLACEMENT WAS CORTISONE THERAPY. THE PHYSICIAN NOTED THAT BOTH LEADS WERE AFFECTED BY EDEMA, BUT IT IS CLEARLY LARGER ON THE LEFT SIDE, WHERE THE LEAD REPLACEMENT PROCEDURE TOOK PLACE. THE PHYSICIAN STATED THAT THE EDEMA EXTENDS THE ENTIRE LENGTH OF THE LEAD, EXPANDING TOWARD THE FRONTAL REGION. THE EDEMA WAS ALSO SYMPTOMATIC, WITH EVIDENT CONFUSION AND SEVERE SPATIO-TEMPORAL DISORIENTATION. PATIENT IS GETTING BETTER WITH THE CONFUSIONAL STATE BEING ALMOST FINISHED AND THE EDEMA HAS GRADUALLY BEEN ADSORBED. A FOLLOW-UP TEST IS PLANNED FOR THE NEXT FEW DAYS WITH A GRADUAL REDUCTION OF THE CORTISONE THERAPY AND CONSEQUENT ACTIVATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A VERY SHARP EDEMA ON THE LEFT SIDE OF THE BRAIN THE DAY AFTER A LEAD REPLACEMENT PROCEDURE. THE ONLY MEDICAL INTERVENTION THAT WAS PROVIDED AFTER THE LEAD REPLACEMENT WAS CORTISONE THERAPY. THE PHYSICIAN NOTED THAT BOTH LEADS WERE AFFECTED BY EDEMA, BUT IT IS CLEARLY LARGER ON THE LEFT SIDE, WHERE THE LEAD REPLACEMENT PROCEDURE TOOK PLACE. THE PHYSICIAN STATED THAT THE EDEMA EXTENDS THE ENTIRE LENGTH OF THE LEAD, EXPANDING TOWARD THE FRONTAL REGION. THE EDEMA WAS ALSO SYMPTOMATIC, WITH EVIDENT CONFUSION AND SEVERE SPATIO-TEMPORAL DISORIENTATION. PATIENT IS GETTING BETTER WITH THE CONFUSIONAL STATE BEING ALMOST FINISHED AND THE EDEMA HAS GRADUALLY BEEN ADSORBED. A FOLLOW-UP TEST IS PLANNED FOR THE NEXT FEW DAYS WITH A GRADUAL REDUCTION OF THE CORTISONE THERAPY AND CONSEQUENT ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872198 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 21747783 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention