BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 1566417 · Received December 14, 2009

    Report

    Report Number
    3005868392-2009-00001
    Event Type
    Other
    Date Received
    December 14, 2009
    Date of Event
    November 9, 2009
    Report Date
    December 11, 2009
    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

    A SYNAPSE BIOMEDICAL REPRESENTATIVE (CLINICAL SPECIALIST) WAS PRESENT FOR THE TESTING CONDUCTED AT THE USER FACILITY ON (B)(4) 2009. RISK OF CARDIAC ARRHYTHMIA IS IDENTIFIED IN THE SURGEON INSTRUCTION MANUAL ON PAGE 12 (SYNAPSE PART #77-0050 REV A): "THERE IS A RISK OF CARDIAC ARRHYTHMIA BEING CAUSED BY THE PLACEMENT OF THE ELECTRODES IN THE CHEST CAVITY." ON PAGE 30 OF THE MANUAL, CLINICIANS ARE INSTRUCTED TO TEST FOR CARDIAC INTERFERENCE: "AN EKG STRIP IS RECORDED WITH ALL FOUR ELECTRODES ACTIVE TO BE SURE THERE IS NO CAPTURE OF THE CARDIAC RHYTHM." THE RECOMMENDED TESTING WAS PERFORMED AT THE TIME OF SURGICAL IMPLANTATION BUT THE INSTRUCTIONS IN THE MANUAL ARE NOT SUFFICIENTLY DETAILED TO INSTRUCT THE CLINICIAN TO TEST FOR CARDIAC RHYTHM CAPTURE WITH THE PATIENT IN VARIOUS POSITIONS. THIS IS A RARE EVENT AND WE DO NOT BELIEVE OTHER PATIENTS ARE AT RISK. WE WILL REVISE THE RELEVANT LABELLING TO INCLUDE MORE DETAILED INSTRUCTIONS FOR TESTING FOR CARDIAC RHYTHM CAPTURE AND SUBMIT THE CHANGE AS A SUPPLEMENT TO THE HDE. ADDITIONAL SERIAL #: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2009, AT (B)(6) HOSPITAL. WHILE UNDERGOING PHYSICAL THERAPY AT NEARBY AND AFFILIATED SHEPHERD CENTER THE PATIENT EXPERIENCED CARDIAC ARREST ON (B)(6) 2009. PATIENT WAS RESUSCITATED AND THE DEVICE WAS TURNED OFF. PATIENT HAS A CARDIAC PACEMAKER THAT WAS OFF AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURX DIAPHRAGM PACING SYSTEM NONE HCC SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-093009-3-3

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R