BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREEPI

    MDR report key: 3953605 · Received July 23, 2014

    Report

    Report Number
    2649622-2014-07663
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    February 20, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. A CALL RECEIVED FROM THE FUNERAL HOME INDICATED THE PATIENT'S REMOTE MONITOR WAS BROUGHT TO THEIR FACILITY IN ORDER TO SEND A FINAL DEVICE TRANSMISSION TO THE CLINIC. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. ADDITIONAL INFORMATION OBTAINED REPORTED THE CAUSE OF DEATH AS: CARDIAC ARREST DUE TO ASYSTOLE COMPLICATIONS BY CONGENITAL HEART DISEASE, TETRALOGY OF FALLOT, VENTRICULAR SEPTAL DEFECT, SINUS BRADYCARDIA, PROLONGED QT INTERVAL STATUS-POST SURGICAL REPAIR OF HEART ANOMALIES AND PACEMAKER. ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES OF THE PATIENT DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL REPORTED THAT THE PATIENT BECAME UNRESPONSIVE AT HOME. AN AMBULANCE WAS CALLED AND THE PATIENT WAS FOUND TO BE IN ASYSTOLE. RESUSCITATION EFFORTS WERE INITIATED AND A PULSE AND RHYTHM RETURNED. UPON ARRIVAL TO THE EMERGENCY ROOM THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY. RESUSCITATION EFFORTS WERE CONTINUED AND WERE NOT SUCCESSFUL. ONE WEEK PRIOR TO DEATH AN ECHOCARDIOGRAM REPORT NOTED MODERATE PULMONARY STENOSIS AND PULMONARY REGURGITATION. THE PATIENT WAS TO HAVE A CARDIAC CATHETERIZATION BUT WAS TO WAIT TO ALLOW FURTHER RECOVERY FROM ATRIAL SEPTAL DEFECT REPAIR TWO MONTHS PRIOR AND RECENT VIRAL ILLNESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430780 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 MO Death ADDR01 IPG, 4968-25 LEAD