BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCOLADE

    MDR report key: 7324898 · Received March 8, 2018

    Report

    Report Number
    2124215-2018-04523
    Event Type
    Death
    Date Received
    March 8, 2018
    Date of Event
    February 19, 2018
    Report Date
    February 19, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    UDI-DI
    00802526559150
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DAYS LATER, THE FIELD REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PASSED AWAY. THE PATIENT'S FAMILY IS ALLEGING THE PACEMAKER CAUSED THE PATIENT'S DEATH. THE DEVICE WAS NOT EXPLANTED POST-MORTEM. DEVICE DATA WAS REVIEWED BY TS. THERE WERE NO EPISODES STORED ON THE DATE OF DEATH AND NO RESETS OR ABNORMAL FAULTS. THE RV PACING IMPEDANCE MEASUREMENTS WERE SHOWING ABRUPT CHANGES TO AROUND 1600 OHMS, WITH FLUCTUATIONS BETWEEN 500-1600 OHMS. NO OUT OF RANGE IMPEDANCES WERE OBSERVED. THE RV INTRINSIC AMPLITUDES WERE WITHIN NORMAL RANGE. THE RV AUTOMATIC THRESHOLD WAS NOT ACTIVATED. THE MOST RECENT IN-OFFICE RV THRESHOLD RESULT WAS 1.1 V/0.5 MS ON (B)(6) 2017, WHICH MATCHES THE RESULT AT IMPLANT. EPISODE V-7 FROM (B)(6) 2017 SHOWED A SHORT RUN OF VENTRICULAR TACHYCARDIA (VT), POSSIBLY DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE BASED ON THE IRREGULAR V-V INTERVALS. THE MINUTE VENTILATION (MV) SIGNAL WAS VISUALLY SEEN ON THIS ELECTROGRAM, BUT THERE WAS NO OVERSENSING OR PACING INHIBITION OBSERVED. THE PRESENTING ELECTROGRAM FROM (B)(6) 2017 AND REMOTE MONITORING DATA ALSO SHOWED THE MV SIGNAL, BUT AGAIN, NO OVERSENSING OR PACING INHIBITION. THE FINAL ELECTROGRAM AVAILABLE WAS THE PRESENTING ELECTROGRAM FROM THE LAST DATA TRANSMISSION ON (B)(6) 2018. THIS ELECTROGRAM SHOWED A CLEAN SIGNAL WITH NO VISIBLE MV SIGNAL APPEARANCE. THE DEVICE APPEARED TO HAVE OPERATED AS PROGRAMMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER AND CHRONIC COMPETITOR LEADS PRESENTED TO THE HOSPITAL EMERGENCY DEPARTMENT DUE TO SYNCOPE. A CONSULT INTERROGATION WAS COMPLETED. TELEMETRY STRIPS FROM A 12-LEAD EKG SHOWED THE PATIENT WAS IN AN ESCAPE RHYTHM IN THE 30 BPM RANGE. THE DEVICE PROGRAMMING WAS VVIR AT 60 BPM AND THE PATIENT WAS IN ATRIAL FIBRILLATION (AF). THE MINUTE VENTILATION FEATURE WAS ALSO PROGRAMMED ON. BASED ON THIS, THERE WAS CONCERN THAT THE DEVICE WAS INHIBITING PACING. A COMPANY FIELD REPRESENTATIVE CHECKED THE DEVICE POST-CONSULT AND OBSERVED NORMAL SENSING, IMPEDANCES, AND THRESHOLD MEASUREMENTS. THERE WERE NO EPISODES STORED WITH NOISE, HOWEVER THERE HAD BEEN INTERMITTENT CHANGES WITH THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND EXPLAINED THE CHANGES IN IMPEDANCES COULD BE RELATED TO THE SPRING CONTACT OR INTERMITTENT LOSS OF CAPTURE SINCE NO NOISE EPISODES WERE STORED. TS DISCUSSED THE OPTION OF PROGRAMMING TO UNIPOLAR PACE AND BIPOLAR SENSE, AND TO MONITOR TO SEE IF THE RV LEAD IMPEDANCE VARIATIONS RESOLVE. THE PHYSICIAN REQUESTED THAT THE FIELD REPRESENTATIVE PROGRAM THE DEVICE TO BE MORE SENSITIVE AND TO INCREASE THE PACING OUTPUTS. THE MV FEATURE WAS ALSO TURNED OFF DURING THIS DEVICE CHECK. LATER THAT NIGHT, THE PATIENT'S RATE DROPPED AGAIN (AROUND 32 BPM). THE PATIENT WAS PLACED ON EXTERNAL PACING SUPPORT AND THE FIELD REPRESENTATIVE WAS CONTACTED TO CHECK THE DEVICE AGAIN AND THEN PROGRAM THE PACING MODE TO VOO. WHEN THE FIELD REPRESENTATIVE ARRIVED TO THE HOSPITAL, THE PATIENT HAD BEEN TRANSFERRED TO ANOTHER HOSPITAL AFTER HAVING A STROKE. UPON ARRIVING TO THE TRANSFERRED HOSPITAL, THE PATIENT WAS IN A SINUS RHYTHM AT 80 BPM. THE DEVICE WAS NOT CHANGED TO VOO PACING MODE, BUT WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION. FOLLOWING THIS PROGRAMMING, NO DECREASED HEART RATES WERE SEEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167353 ACCOLADE IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND L300 00802526559150

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| H| L| R 4068| 5068| ADDR01| L300