BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 5634764 · Received May 5, 2016

    Report

    Report Number
    3015876-2016-00541
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    March 24, 2016
    Report Date
    May 5, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE REPORTED EVENT WAS PERFORMED BY A PHYSIO-CONTROL CLINICAL SPECIALIST AND A PRINCIPAL SCIENTIST. THE REVIEW CONCLUDED THAT THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR A USE ERROR. THE PATIENT¿S QRS COMPLEXES PRIOR TO THE ATTEMPTED SYNCHRONIZED CARDIOVERSION SHOCK HAD STEEP SLOPES AT THE BEGINNING AND END OF THE COMPLEXES, AND THE QRS DETECTION POINT USED BY THE DEFIBRILLATOR FOR THE SYNCHRONIZED SHOCK SWITCHED FROM THE BEGINNING OF THE QRS COMPLEX TO THE END SLOPE OF THE QRS COMPLEX IMMEDIATELY BEFORE THE SHOCK WAS ADMINISTERED AND THE PATIENT¿S ECG RHYTHM CONVERTED TO A POLYMORPHIC VENTRICULAR TACHYCARDIA. THE DEVICE QRS DETECTOR, WHICH IS DESIGNED TO TRIGGER ON STEEP SLOPES IN THE QRS COMPLEXES, PERFORMED CONSISTENTLY WITH ITS DESIGN. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL THAT THEY WERE PERFORMING A SYNCHRONIZED CARDIOVERSION PROCEDURE ON A PATIENT WITH ATRIAL FIBRILLATION (A-FIB). THEY INDICATED THAT THE DEVICE WAS SYNCING APPROPRIATELY TO THE QRS COMPLEX ON EVERY HEART BEAT EXCEPT THE HEART BEAT IMMEDIATELY PRIOR TO THE DELIVERY OF THE FIRST SYNCHRONIZED SHOCK. FOLLOWING THE DELIVERY OF THE SHOCK, THE PATIENT'S RHYTHM CONVERTED TO VENTRICULAR FIBRILLATION. THE PHYSICIAN STATED THEY WERE ABLE TO CONVERT THE PATIENT OUT OF V-FIB INTO A POLYMORPHIC VENTRICULAR TACHYCARDIA RHYTHM. THE PATIENT HAD AN IMPLANTED CRT-D (CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR), WHICH THEN DELIVERED A SUPPLEMENTAL DEFIBRILLATION SHOCK TO THE PATIENT AND CONVERTED THE PATIENT'S RHYTHM TO AN AV SEQUENTIAL PACING RHYTHM. THE PATIENT DID SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288781 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention