BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION/MEDICAL DATA ELECTRONICS

    MDR report key: 1534684 · Received November 18, 2009

    Report

    Report Number
    1051786-2009-00012
    Event Type
    Death
    Date Received
    November 18, 2009
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MLD
    PMA / PMN Number
    K982104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULTS: THE DEVICE MANUFACTURER DIALED INTO THE USER'S SYSTEM AND DOWNLOADED LOG FILES. THE DATA OBTAINED OUTLINED ALL THE ALERTS CALLED BY THE DEVICE DURING THE USER'S PERIOD OF INTEREST. A COPY OF THE DATA DOWNLOADED FROM THE USER'S DEVICE WAS SENT TO THE USER. REVIEW OF THE ALERT DATA SHOWED THAT THE DEVICE WAS PROVIDING ALERTS APPROPRIATELY IN RESPONSE TO ARRHYTHMIA EVENTS OCCURRING, SUCH AS VTACH, RUN, SLOW RUN AND ARRHYTHMIA HEART RATE LOW AND HIGH ALERTS. IT WAS ALSO NOTED BY LOOKING AT THE ALERT LOG FILE THAT THERE WAS MANY TIMES WHERE THE USER WAS ALERTED TO MANY ECG NOISE, ECG-ALL LEAD FAIL AND BAD ECG SIGNAL CONDITIONS. THESE CONDITIONS BEGAN TO APPEAR ON THE LOG AT A REGULAR BASIS AT 6:25 AND CEASE TO APPEAR ON A REGULAR BASIS AT APPROXIMATELY 6:35. CORRELATION BETWEEN THESE "NOISE" ALERTS AND THE ACTUAL ARRHYTHMIA HEART RATE DATA CAN BE SEEN. AT 6:26:54, THE PATIENT'S HEART RATE WAS 162. IMMEDIATELY AFTER THIS TIME, THE PATIENT'S HEART RATE APPEARED TO CHANGE TO 91, THEN 93, 90, 57. THE PATIENT'S HEART RATE APPEARS TO AVERAGE IN THE 50'S, THEN JUMPS TO 279 AT 6:36. AT 6:36, THE SYSTEM CALLS A VTACH ALERT. ALTHOUGH IT CANNOT BE CONFIRMED, IT IS BELIEVED THAT THE HEART RATES THAT AVERAGED IN THE 50'S WERE NOT THE PATIENT'S ACTUAL HEART RATE, BUT WERE ECG NOISE. ACCORDING TO THE DEVICE'S LABELING (INSTRUCTIONS FOR USE), THE DEFINITION OF THESE CONDITIONS IS: ECG NOISE: "NOISE HAS BEEN DETECTED ON THE ECG SIGNAL", ECG-ALL LEAD FAIL: "ALL LEADS FAILED", BAD ECG SIGNAL: "THE ECG SIGNAL BEING RECEIVED IS BAD". THESE ALERTS ARE INDICATIVE OF EITHER A BAD ECG SIGNAL BEING RECEIVED OR NOISE BEING DETECTED. THE INSTRUCTIONS FOR USE PROVIDE GUIDANCE AND RECOMMENDATIONS FOR OBTAINING OPTIMAL ARRHYTHMIA PERFORMANCE: "THE BEST WAY TO ACHIEVE THE OPTIMAL PERFORMANCE FROM THE ARRHYTHMIA ALGORITHM IS TO PROVIDE THE SYSTEM WITH AS CLEAN AN ECG SIGNAL AS POSSIBLE. THE FOLLOWING GUIDELINES CAN BE USED TO OPTIMIZE PERFORMANCE AND MINIMIZE FALSE CALLS. UTILIZE DUAL VECTOR PROCESSING WHENEVER POSSIBLE. DUAL VECTOR PROCESSING PROVIDES THE ALGORITHM WITH MORE INFORMATION WITH WHICH TO MAKE DECISIONS AND VALIDATE DATA. ADJUST THE WAVEFORM SIZE TO A MID-RANGE LEVEL THAT ALLOWS FOR GOOD R-WAVE DISTINCTION AND DOES NOT OVER EMPHASIZE THE T-WAVE. IF A PARTICULAR LEAD IS NOT GENERATING AN APPROPRIATE SIGNAL, SWITCH TO A DIFFERENT PRIMARY VECTOR (LEAD I OR III) OR RE-POSITION THE ELECTRODES TO EXAMINE A MORE DISTINCTIVE CARDIAC SIGNAL. SUBTLE CHANGES IN MORPHOLOGY CAN OFTEN LEAD TO THE INCORRECT CLASSIFICATION OF BEATS. A RELEARN SHOULD BE DONE WHENEVER A MORPHOLOGY CHANGE IS OBSERVED, PARTICULARLY AFTER A DRUG INFUSION OR CONVERSION. UTILIZE THE BEAT LABELING FEATURE IN FULL DISCLOSURE TO DETERMINE IF THE ALGORITHM IS CONSISTENTLY MISCLASSIFYING BEATS. IF SO, INITIATING A RELEARN WILL CAUSE THE ALGORITHM TO THROW OUT ITS PREVIOUS KNOWLEDGE OF THE PATIENT'S ECG AND BEGIN TO OBTAIN A NEW NORMAL. IF PATIENT HAS A PACEMAKER, TURN ON PACER DETECTION IN ECG." THE USER WANTED TO KNOW THE ALARM SETTINGS AT THE TIME OF THE PATIENT'S DEATH, BUT THIS EXACT INFORMATION COULD NOT BE PROVIDED TO THEM WITHOUT THE USER ACTUALLY REMOVING THE DEVICE FROM SERVICE AND SENDING THE DEVICE IN FOR EVALUATION. THE USER INDICATED THAT THEY CHOSE TO KEEP THE DEVICE IN SERVICE. THE USER INDICATED THAT AT NO TIME DID THEY BELIEVE THAT THE DEVICE MALFUNCTIONED AND THAT THEIR PURPOSE FOR ASKING FOR THE VITAL SIGNS DATA WAS NOT TO DETERMINE WHETHER OR NOT THE DEVICE MALFUNCTIONED BUT FOR "OTHER" PURPOSES. WHEN ASKED FURTHER FOR THE REASON FOR THE DATA REQUEST, THE USER DECLINED TO PROVIDE ANY MORE INFORMATION. THE DEVICE MANUFACTURER CONSIDERS THAT THERE WAS NO MALFUNCTION OR LABELING PROBLEM. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THE FAILURE OF THE USERS TO RESOLVE THE INOP CONDITIONS HAD ANY IMPACT ON THE PATIENT OUTCOME.

    Description of Event or Problem · 1

    THE USER FACILITY CONTACTED THE DEVICE MANUFACTURER TO INQUIRE ABOUT THE ALARM SETTINGS AT THE TIME OF A PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION/MEDICAL DATA ELECTRONICS ESCORT VISION CENTRAL STATION MLD INVIVO CORPORATION 20500-16

    Patients

    Seq Age Sex Outcome Treatment
    1 Death