DYNAGEN™ EL (Extended Longevity) ICD
Contents
1. to 400 ms Rate Hystersis Events summary Stored Electrograms with Annotated Markers Intervals and approximately 17 minutes of multi channel EGM always with 10 seconds Onset and event storage prioritization Implant activation of all available EGMs On screen measurement of all stored signal amplitudes and timing Tachy Events and Brady Counters SDANN and HRV Footprint 24 hour heart rate collection period Events Activity Level Atrial Burden Respiratory Rate Heart Rate SDANN HRV Footprint Autonomic Balance Monitor ABM Lead impedances and amplitudes To note Automatic activation of all available daily trends at implant Atrial Burden Daily burden Average V rate during ATR Mode Switch Episode HF Perspectiv Report Respiratory Rate Trend Weight Tachyarrhythmia Therapy Sensing Detection Shock Reduction and Appropriate Therapy Antitachycardia Pacing Therapy ATP Termination Shock Energy Nominals Zones VF only or VF and VT or VF VT VI 1 Lowest Zone can be Monitor Only AcuShock Advanced Technology including Onset Stability Rhythm ID with RhythmMatch Dynamic Noise Algorithm DNA for sensing Automatic Gain Control AGC with programmable sensing floor Narrow Band Pass Filter Quick Convert in VF Zone Two programmable ATP schemes in both VT and VT 1 zones Burst Ramp Scan Ramp Scan 41 J stored 35 J delivered First two shocks in each zone programmable VT 1 has 5 sh2. 00389 3 fulltext 5 Boston Scientific CRM Product Performance Report Data on file 6 Competitive comparisons PHYSICIAN S TECHNICAL MANUAL DYNAGEN EL ICD DYNAGEN MINI ICD INOGEN EL ICD INOGEN MINI ICD ORIGEN EL ICD ORIGEN MINI ICD 2014 page 27 29 PUNCTUA ICD ENERGEN ICD INCEPTA ICD PHYSICIAN S TECHNICAL MANUAL 2012 page 40 41 PROTECTA XT VR D314VRM 2013 page 330 EVERA XT VR DVBB1D4 2013 page 24 AnalyST AnalyST Accel Current Current Accel Fortify Fortify ST Promote Promote Accel Promote Q Unify Devices User s Manual 2013 page 29 St Jude Medical High Voltage Devices User s Manual 2013 page 16 llesto 7 Family of ICDs and CRT Ds Technical Manual 2013 page 217 ICD Systems from Boston Scientific DYNAGEN EL ICD DYNAGEN MINI ICD INOGEN EL ICD INOGEN MINI ICD ORIGEN EL ICD ORIGEN MINI ICD Indications and Use Boston Scientific implantable cardioverter defibrillators ICDs are intended to provide ventricular antitachycardia pacing ATP and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias Contraindications Use of these Boston Scientific pulse generators are contraindicated for the following patients whose ventricular tachyarrhythmias may have reversible cause such as digitalis intoxication electrolyte imbalance hypoxia sepsis or patients whose ventricular tachyarrhythmias have a transient caus
3. Boston fo cient Advancing science for life DYNAGEN EL Extended Longevity ICD Models D150 D151 D152 and D153 e Designed to be the world s longest lasting ICD e Powered by ENDURALIFE Battery Technology which enables the longest projected longevities backed by four independent studies and over six years of real world data e The world s thinnest ICD designed to enhance patient comfort e Includes the new EasyView header with color coded lead ports designed to improve implant efficiency e Offers an uncompromised set of features including An advanced system solution for patient comorbidities and HF monitoring HF Perspectiv Report LATITUDE NXT Remote Patient Management enabled with weight scale and blood pressure sensors and Respiratory Rate Trend AcuShock Advanced Technology multiple programmable options to reduce inappropriate and unnecessary shocks including a choice of rhythm discriminators antitachycardia pacing ATP therapy in all rates zones and advanced sensing and filtering Rhythm ID with RhythmMatch allows customization of Rhythm ID algorithm to reduce inappropriate shocks AV Search and Rythmiq give clinicians options to appropriately manage RV pacing in patients with varying degrees of conduction block Wireless ECG saves time and simplifies follow up Safety Core technology is intended to provide lifesaving shock therapy and basic pacing
4. al when the Connector Tool is not present on the lead Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA alligator clips ECG connections forceps hemostats and clamps Do not contact any other portion of the DF4 LLHH or DF4 LLHO lead terminal other than the terminal pin even when the lead cap is in place Do not use this pulse generator with another pulse generator This combination could cause pulse generator interaction resulting in patient injury or a lack of therapy delivery Do not kink twist or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias Precautions For specific information on precautions refer to the following sections of the product labeling clinical considerations sterilization and storage implantation device programming environmental and medical therapy hazards hospital and medical environments home and occupational environments follow up testing explant and disposal supplemental precautionary information Potential Adverse Effects Potential adverse events include but are not limited to the following allergic physical physiologic reaction death erosion migration fibrillation or other arrhythmias lead or accessory breakage fra
5. ata during a symptomatic episode by placing a magnet over the device Beep During Capacitor Charge Beep when Explant is Indicated Beep when Lead Impedance measurement Shock or Pace is Out of Range Magnet Response Off Store EGM Inhibit Therapy This device is LATITUDE enabled Remote follow up for all devices MICS 1 Alam M Munir B Rattan R Flanigan S Adelstein E Jan S Saba S Battery Longevity in Cardiac Resynchronization Therapy Defibrillators 2013 Europace 2013 doi 10 1093 europace eut301 First published online October 6 2013 2 J Hjortshoj S Johansen J Jorgensen O Nielsen J Petersen H Device Longevity in Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillators Differs Between Manufacturers Data from the Danish ICD Registry Presented at HRS 2014 3 Ellis C Markus T Dickerman D Orton J Hassan S Good E Okabe T Greenspon A Ampere Hour as a Predictor of CRT ICD Pulse Generator Longevity A Multi Center Study Presented at HFSA 2014 http www onlinejcf com article S1071 9164 14 00337 6 fulltext 4 J Williams R Stevenson Contemporary Cardiac Resynchronization Implantable Cardioverter Defibrillator Battery Longevity in a Community Hospital Heart Failure Cohort Presented at HFSA 2014 HYPERLINK http www onlinejcf com article S1071 9164 14 00389 3 fulltext http HYPERLINK http www onlinejcf com article S1071 9164 14 00389 3 fulltext www onlinejcf com article S1071 9164 14
6. cture insulation lead tip hematoma seroma inappropriate or inability to provide therapy shocks pacing sensing infection procedure related and component failure Patients may develop psychological intolerance to a pulse generator system and may experience fear of s hocking fear of device failure or imagined s hocking In rare cases severe complications or device failures can occur Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev A Boston Scientific Advancing science for life Rhythm Management 300 Boston Scientific Way Marlborough MA 01752 1234 www bostonscientific com Medical Professionals 1 800 CARDIAC 227 3422 Patients and Families 1 866 484 3268 2015 Boston Scientific Corporation or its affiliates All rights reserved CRM 268607 AB JAN2015
7. e such as acute myocardial infarction MI electrocution drowning or patients who have a unipolar pacemaker Warnings Read this manual thoroughly before implantation to avoid damage to the pulse generator and or lead For single patient use only Do not reuse reprocess or resterilize Program the pulse generator Tachy Mode s to Off during implant explant or postmortem procedures to avoid inadvertent high voltage shocks Always have external defibrillation equipment available during implant and electrophysiologic testing Ensure that an external defibrillator and medical personnel skilled in CPR are present during post implant device testing should the patient require external rescue Patients should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device including areas protected by a warning notice that prevents entry by patients who have a pulse generator Do not expose a patient to MRI scanning Do not subject a patient with an implanted pulse generator and or lead to diathermy If desired ensure that Patient Triggered Monitor is enabled prior to sending the patient home Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored or after 60 days have elapsed from the day that Store EGM was enabled the patient should not apply the magnet For leads that require the use of a Connector Tool use caution handling the lead termin
8. functionality in the event of an unrecoverable fault Mechanical Specifications and Reimbursement Information Size cm Mass Volume Connector Type Model Type W x H x D g cc RA RV LV C Code D150 VR 5 37 x 7 36 x 0 99 68 9 29 5 RV DF4 C1722 D151 VR 5 37 x 7 79 x 0 99 70 7 S15 RV IS 1 DF 1 C1722 D152 DR 5 37 x 7 68 x 0 99 71 4 31 0 RA IS 1 RV DF4 1721 D153 DR 5 37 X 7 79 X 0 99 71 0 31 5 RA IS 1 RV IS 1 DF 1 C1721 Pulse Generator Projected Longevity All Models 2 Longevity years at 5000 7000 and 900 Pacing Impedance RV 5000 7000 9000 Pacing VR DR VR DR VR DR 50 11 1 10 1 11 2 10 2 a Assumes Zip telemetry use for 1 hour at implant time and for 40 minutes annually for in clinic follow up checks b Assumes standard use of the LATITUDE Communicator as follows Daily Device Check on monthly Full Interrogations scheduled remote follow ups and quarterly patient interrogations c Assumes 60 min LRL ventricular and atrial settings of 2 5 V pacing pulse Amplitude and 0 4 ms pacing pulse width RA Impedance 5000 sensors On d Projected longevity is calculated assuming 3 maximum energy charging cycles per year including automatic capacitor re forms and therapeutic shocks For the final year of device service an additional 5 charging cycles are assumed to account for additional automatic capacitor re forms as the device approaches the Explant indicator These calculations also assume 3 channel EGM Onset is set to On a
9. nd that the pulse generator spends 6 months in Storage mode during shipping and storage Additional Longevity Information e For longevity calculations based on different settings please contact Boston Scientific technical services or your local representative e Boston Scientific devices have corporate warranties at 10 years VR and 8 years DR See BostonScientific com warranty for complete warranty terms and conditions e Devices use Li MnQ2 chemistry e The Usable Battery Capacity is 1 9 Amp hours for the EL ICD typical implant to battery capacity depleted e Shelf life is 2 years before use by Longevity projections as provided in the product labeling Specific programmable parameter ranges available in product labeling Product labeling available at BostonScientific com ifu DYNAGEN EL Extended Longevity ICD Models D150 Pacing Therapy Brady Modes AT AF Management Rate Adaptive Pacing RV Pacing Reduction Patient Diagnostics Arrhythmia Logbook Histograms amp Counters Heart Rate Variability HRV Daily Trends For Last 365 Days AT AF Diagnostics Heart Failure Therapy D151 D152 and D153 Normal DDD R DDI R VDD R VVI R AAI R Off Temporary DDD DDI DOO VDD VVI VOO AAI AOO Off ATR Mode Switch Ventricular Rate Regulation VRR Atrial Flutter Response AFR PMT Termination Rate Smoothing Accelerometer with sensor trending function AV Search Rythmig AV Delays
10. ocks VT has 6 shocks and VF has 8 shocks Reverse Last Shock Polarity in zone Programmable RV Coil to RA Coil and Can TRIAD RV Coil to Can RV Coil to RA Coil COLD CAN VF Zone 200 min Detection Rate and Duration Therapy Quick Convert 8 high energy shocks VT Zone 160 min Detection RhythmID or OBDE Therapy ATP x 2 6 high energy shocks Implant In Clinic Follow Up Implant Communication Mode In clinic Follow Up Programmable values Enable use of Zip telemetry MICS Requires initial use of wand for device ID or use wand for all telemetry Nominal Enable use of Zip telemetry Requires initial use of wand for device ID Wireless ECG Diagnostics Blood Pressure Heart Rates HRV Footprint SDANN Autonomic Balance Monitor ABM Atrial Arrhythmia Burden Activity Level A amp V Arrhythmias Pacing Histograms To note Weight and Blood Pressure are only available via LATITUDE Remote Follow Up Patient Triggered i i i Monitor PTM Device Testing Induction Methods omer Beeper Feature Induction Methods Vfib Induction Shock on T Induction Programmed Patient Alerts Electrical Stimulation PES 50 Hz Manual Burst Pacing Magnet Feature Commanded Therapy Commanded Shock Commanded ATP Methods Remote Monitoring All trademarks are the property of their respective owner Wireless Triggers the storage of two minutes onset and one minute post EGMs intervals and annotated marker d
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