BEUDAMED
    FDA Adverse Event Death Summary report: N

    1220908-2017-00825

    MDR report key: 6493857 · Received April 14, 2017

    Report

    Report Number
    1220908-2017-00825
    Event Type
    Death
    Date Received
    April 14, 2017
    Date of Event
    March 22, 2017
    Report Date
    March 24, 2017
    PMA / PMN Number
    K100654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. REVIEW OF THE CLINICAL DATA INDICATED THAT PACING WAS ACTIVE AND THEN INTERMITTENTLY ACQUIRED. THE DATA SHOWED THAT THERE WAS NOISE ON THE ECG SIGNAL, WHICH INCREASED THE HEART RATE AND THE CAPTURE WAS LOST. ECG NOISE WILL CAUSE THE HEART RATE TO INCREASE AS THE DEVICE DETECTS THE EXTRA PEAKS AS AN R WAVE (UP TO 215 BPM DURING THIS EVENT). ON DEMAND PACER/CAPTURE WORKS WHEN THE PATIENT'S HEART RATE FALLS BELOW THE SET PPM. WHEN THE HEART RATE INCREASES ABOVE THE SET HEART RATE (80 AND 100 IN THIS CASE) PACING STOPS. THERE IS A TWO MINUTE PERIOD WHERE THE DEVICE CAPTURED CONSISTENTLY. THE ECG SIGNAL NOT BEING CONSISTENTLY CAPTURED IS NOT NECESSARILY A DEVICE MALFUNCTION AS A NOISY ECG SIGNAL CAN AFFECT THE FUNCTIONALITY OF ON DEMAND PACING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6) YEAR OLD MALE PATIENT, THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death