BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 2160621 · Received July 6, 2011

    Report

    Report Number
    3005868392-2011-00002
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 4, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    HCC
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION PROVIDED BY THE IMPLANTING SURGEON AND A CONSULTING CARDIOLOGIST, WE ARE UNABLE TO DETERMINE IF USE OF THE NEURX DPS CAUSED OR CONTRIBUTED TO THIS EVENT. AN ATTEMPT TO DETECT ANY CARDIAC RHYTHM DISTURBANCE IN A CONTROLLED SETTING WAS NOT SUCCESSFUL IN INDUCING SUSTAINED ARRHYTHMIAS. THE CONSULTING CHIEF MEDICAL OFFICER OF THE COMPANY ((B)(6) MD) HAS REVIEWED THE INFORMATION AVAILABLE AND HAS ADVISED THAT IN HIS OPINION: "EITHER HIS [THE PATIENT'S] CARDIAC CHANGES FROM THE PE [PULMONARY EMBOLISM] HAD IMPROVED WITH LESS PULMONARY HYPERTENSION AND CARDIAC WORKLOAD OR THERE HAD NEVER BEEN ANY INTERACTION FROM DP TO THE EVENT OF THE ARRHYTHMIA, WHICH IS THE MORE LIKELY EXPLANATION. THIS PATIENT HAD BECOME A HIGHER RISK OF ARRHYTHMIAS BECAUSE OF THE CARDIOPULMONARY EFFECTS OF THE MASSIVE PE. WHEN A CHANGE LIKE THIS OCCURS, THE PATIENT HAS DEVELOPED A NEW HEART PROBLEM AND SHOULD BE EVALUATED AT HIGHEST DP SETTINGS SUCH AS IS DONE DURING THE INITIAL SURGICAL IMPLANTATION." WE CONCLUDE THAT EITHER THE NEURX DPS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT OR, IF THE DEVICE DID CONTRIBUTE TO THE EVENT INITIALLY, THE UNDERLYING CARDIAC CONDITIONS THAT CREATED A PREDISPOSITION TO INDUCED ARRHYTHMIAS RESOLVED ENOUGH DURING THE PERIOD BETWEEN THE EVENT AND THE CONTROLLED EVALUATION THAT THE PATIENT WAS NO LONGER SUSCEPTIBLE TO INTERFERENCE BY THE TIME THE CONTROLLED EVALUATION WAS PERFORMED. THEREFORE, WE CAN IDENTIFY NO CORRECTIVE OR PREVENTIVE ACTIONS BEYOND THE WARNINGS, PRECAUTIONS, AND INSTRUCTIONS ALREADY PROVIDED TO CLINICIANS AND PATIENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT EXPERIENCED ARRHYTHMIA AND CARDIAC ARREST AND RECEIVED RESUSCITATION MEASURES. THE PATIENT HAS SUBSEQUENTLY RECOVERED. DUE TO THE POTENTIAL FOR CARDIAC INTERACTION IN A PATIENT WITH HEART PROBLEMS, THIS EVENT HAS BEEN INVESTIGATED. A REPORT FROM THE NOTIFYING PHYSICIAN, DR. (B)(6) IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURX DIAPHRAGM PACING SYSTEM HCC SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-070109-1-1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention