BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5517242 · Received March 22, 2016

    Report

    Report Number
    2183461-2016-00004
    Event Type
    Injury
    Date Received
    March 22, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 22, 2016
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    MHX
    PMA / PMN Number
    K060135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM LOG FILES WERE REVIEWED. EVENT INVOLVED A (B)(6) FEMALE WITH AN IMPLANTED DEFIBRILLATOR. THE PATIENT WAS IN VENTRICULAR TACHYCARDIA WITH LOW QRS AMPLITUDE IN MOST OF THE PRECORDIAL LEADS. THE AMPLITUDE OF THE BEATS IN THE DETECTION LEADS WAS BELOW THE THRESHOLD OF 0.3 MV RESULTING IN SOME BEATS NOT BEING DETECTED. THE QRS-AMPLITUDE IN V1 WAS SYSTEMATICALLY LOWER THAN 0.3 MV AND V5 WAS JUST ABOVE THE THRESHOLD, CAUSING A BEAT TO BE MISSED EVEN IN NORMAL RHYTHM. THE OPERATOR HAD LOWERED THE DETECTION THRESHOLD OF THE SYSTEM TO 0.3 MV, BUT DID NOT CHANGE THE DETECTION LEADS FROM THE DEFAULT OF V1 AND V5. A DIFFERENT DETECTION LEAD WOULD HAVE PREVENTED BEATS BEING MISSED. DURING A PERIOD OF NORMAL SINUS RHYTHM A FALSE "LOW HEART RATE" ALARM WAS GENERATED DUE TO THE LOW QRS-AMPLITUDE. DURING A SHORT EPISODE OF ALTERNATE VENTRICULAR CONDUCTION THE LOW QRS AMPLITUDE GENERATED A FALSE ASYSTOLE ALARM. BOTH FALSE ALARMS SHOULD HAVE ALERTED THE OPERATOR TO SELECT A DIFFERENT DETECTION LEAD, PARTICULARLY FOR V1. THE INVESTIGATION INDICATES THAT THE SYSTEM WAS OPERATING NORMALLY AND WITHIN PERFORMANCE SPECIFICATIONS. THE INFORMATION REVIEWED DID NOT INDICATE THERE WAS ANY SYSTEM MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. HOWEVER, THE PATIENT'S IMPLANTABLE DEFIBRILLATOR DID DISCHARGE DURING THE EVENT AND INTERVENED TO PRESUMABLY PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION. THE SURVEYOR CENTRAL WAS, OR MAY HAVE BEEN, A FACTOR IN THE EVENT AS A RESULT OF USER ERROR WHEN THE USER DID NOT SELECT A DETECTION LEAD WITH HIGHER QRS AMPLITUDE. THE INVESTIGATION IS COMPLETE AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURVEYOR SYSTEM FAILED TO DETECT A VENTRICULAR TACHYCARDIA. THE PATIENT'S IMPLANTABLE DEFIBRILLATOR DISCHARGED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174302 SURVEYOR CENTRAL SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC. SCSYS-EED-KBEAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| O