BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA

    MDR report key: 1962670 · Received January 18, 2011

    Report

    Report Number
    6000094-2011-00011
    Event Type
    Death
    Date Received
    January 18, 2011
    Date of Event
    August 6, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. BASED ON FOLLOW-UP RECEIVED FROM TRANSLATION, THE PATIENT EXPERIENCING SYNCOPE WAS TAKEN BY AMBULANCE TO THE HOSPITAL. THE ELECTRO-CARDIOGRAM SHOWED ATRIAL FIBRILLATION AND WAS TREATED WITH MEDICATIONS. DURING TRANSPORT, THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA AND TWO SHOCKS WERE DELIVERED WHICH THAN PROGRESSED TO VENTRICULAR FIBRILLATION. THE ELECTRO-CARDIOGRAM SHOWED DECREASED LEFT VENTRICLE FUNCTION, PULMONARY HYPERTENSION. PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS TREATED FOR HEMODYNAMIC INSTABILITY, ACUTE RENAL INSUFFICIENCY, AND AN AORTIC BALLOON WAS PLACED FOR CARDIAC SUPPORT. THE PATIENT'S CLINICAL STATE DETERIORATED WITH PROGRESSIVE CARDIOGENIC SHOCK LEADING TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST DEVICE IMPLANT. THE PATIENT HAD AN ARRHYTHMIC VENTRICULAR TACHYCARDIA EVENT WHICH EVALUATED INTO VENTRICULAR FIBRILLATION. THE PATIENT RECEIVED TWO SHOCKS WHEREAFTER THE PATIENT WENT IN CARDIOGENIC SHOCK AND DIED. PHYSICIAN INDICATED ON THE (B)(4) STUDY FORM THAT THE PRIMARY CAUSE OF DEATH TO BE VENTRICULAR TACHYCARDIA. BASED ON FOLLOW-UP RECEIVED, IT WAS REPORTED THAT THE PATIENT HAD SHORTNESS OF BREATH AND HAD A CARDIORESPIRATORY COLLAPSE AT HOME. THE PATIENT HAD VENTRICULAR TACHYCARDIA WHICH CHANGED TO VENTRICULAR FIBRILLATION AND THE PATIENT RECEIVED TWO SUCCESSFUL SHOCKS. THE PATIENT WAS HOSPITALIZED AND RECEIVED AN ASSIST DEVICE FOR PUMP FUNCTION. THE PATIENT WENT INTO CARDIOGENIC SHOCK AND DIED. THE CAUSE OF DEATH IS CARDIOGENIC SHOCK. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEADS RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST DEVICE IMPLANT. THE PATIENT HAD AN ARRHYTHMIC VENTRICULAR TACHYCARDIA EVENT WHICH EVALUATED INTO VENTRICULAR FIBRILLATION. THE PATIENT RECEIVED TWO SHOCKS, WHEREAFTER THE PATIENT WENT IN CARDIOGENIC SHOCK AND DIED. PHYSICIAN INDICATED ON THE (B)(4) CLINICAL STUDY FORM THAT THE PRIMARY CAUSE OF DEATH TO BE VENTRICULAR TACHYCARDIA. (B)(6) 2011 BASED ON FOLLOW-UP RECEIVED, IT WAS REPORTED THAT THE PATIENT HAD SHORTNESS OF BREATH AND HAD A CARDIORESPIRATORY COLLAPSE AT HOME. THE PATIENT HAD VENTRICULAR TACHYCARDIA WHICH CHANGED TO VENTRICULAR FIBRILLATION AND THE PATIENT RECEIVED TWO SUCCESSFUL SHOCKS. THE PATIENT WAS HOSPITALIZED AND RECEIVED AN ASSIST DEVICE FOR PUMP FUNCTION. THE PATIENT WENT INTO CARDIOGENIC SHOCK AND DIED. THE CAUSE OF DEATH IS CARDIOGENIC SHOCK. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEADS RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST DEVICE IMPLANT. THE PATIENT HAD AN ARRHYTHMIC VENTRICULAR TACHYCARDIA EVENT WHICH EVALUATED INTO VENTRICULAR FIBRILLATION. THE PATIENT RECEIVED TWO SHOCKS WHEREAFTER THE PATIENT WENT IN CARDIOGENIC SHOCK AND DIED. PHYSICIAN INDICATED THAT THE PRIMARY CAUSE OF DEATH WAS VENTRICULAR TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D234TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| R