BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIAC PACEMAKER

    MDR report key: 4199030 · Received October 19, 2014

    Report

    Report Number
    MW5038765
    Event Type
    Death
    Date Received
    October 19, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 19, 2014
    Manufacturer
    BIOTRONIK
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS IN THE ED FOR BLOOD IN HIS URINE CATHETER BAG AND UNEXPLAINED WEAKNESS. UPON OUR ARRIVAL IN THE ED I WAS TOLD THAT HE WAS GOING TO (B)(6) FOR A UROLOGY CONSULT. PT WAS LYING IN BED, SUPINE SECONDARY TO WEAKNESS. RN STATED THAT THE PT SAT UP TO EAT LUNCH, WHICH HE DID, AND WAS DIZZY DURING THIS EVENT. HE WAS LAID BACK DOWN SECONDARY TO THE DIZZINESS AND A SECOND BAG OF NACL WAS STARTED; IT WAS DIRECTED TO FLOW THIS AT 1,000 CC/HR FOR THE HYPOTENSION PER DR (B)(6). PT WAS DIZZY; OTHERWISE ASYMPTOMATIC. HE WAS LIFTED WITH A SHEET TO THE GURNEY AND MOVED TO THE AMBULANCE. VITALS ASSESSED AND TRANSPORT WAS INITIATED TO (B)(6). HR AT THE TIME NOTED TO BE IN THE 80'S PER THE SPO2 MONITOR. AT (B)(6) THE PT BEGAN COMPLAINING OF BEING HOT. HE ASKED ME TO REMOVE THE BLANKETS AND TURN ON SOME AIR. AT (B)(6) I NOTICED THAT HE WAS DIAPHORETIC AND APPEARED IN PAIN. HE BEGAN RUBBING HIS CHEST. HE STATED THAT IT FELT LIKE THERE WAS BAND ACROSS HIS CHEST THAT WAS SQUEEZING HIM. I INSTRUCTED (B)(6) TO PULL OVER AT (B)(6) SO THAT WE COULD BETTER ASSESS HIS CHANGE IN CONDITION. CARDIAC MONITORING WAS ESTABLISHED PRIOR TO REACHING THE EXIT. PT WAS NOTED TO BE IN A PACED RHYTHM AT 120 BPM. WE STOPPED AT THE EXIT; (B)(6) CAME INTO THE BACK TO ASSIST IN PT CARE. THE TIME IS APPROXIMATELY 1420HRS. I STARTED A SECOND IV ON THE PT. UPON COMPLETION OF THIS THE PT STATED THAT HE WAS FEELING MUCH BETTER. THE PAIN WAS GONE, HIS DIAPHORESIS HAD SUBSIDED AND HIS DIZZINESS WAS BETTER; HOWEVER, STILL SLIGHTLY PRESENT. AT THIS TIME HIS HEART RHYTHM WAS NOTED TO BE IN THE 80'S IN A PACED RHYTHM. HIS BP WAS THE SAME AS DEPARTURE FROM (B)(6); 104 SYSTOLIC. WE CONTINUED ON WITH OUR TRIP AT THIS TIME. THE TIME IS APPROXIMATELY 1425 HRS. ON (B)(6) MIN WAS STARTED ON THE PT. PT STATED THAT HE HAS FELT THIS PAIN BEFORE WITH HIS LAST MI. PT REPORTS THAT OVER THE PAST TWO DAYS HE HAS BEEN EXPERIENCING THIS PAIN BUT NOT AS BAD; HE DENIES THAT HE REPORTED THIS TO FAMILY OR ED PHYSICIAN. THE PT REMAINED SYMPTOM FREE AND OF NORMAL MENTATION UNTIL THE FOLLOWING SUDDEN ONSET EPISODE: AT APPROXIMATELY 1432 HOURS THE PT HAD A WITNESSED SEIZURE, HIS HEAD DEVIATED TO THE RIGHT. THE SEIZURE LASTED 1 MINUTE AND WAS TONIC/ CLONIC IN NATURE. AFTER THE SEIZURE STOPPED IT WAS NOTED THAT THE PT WAS APNEIC AND UNRESPONSIVE. HIS HEART RATE WAS NOTED TO BE 120 BPM IN A PACED RHYTHM. PT WAS FOUND TO BE PULSELESS AND CPR WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664353 CARDIAC PACEMAKER CARDIAC PACEMAKER MRM BIOTRONIK LUMAX 340 DR-T

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death