Table of Contents
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Table of Contents
Related Manuals for St. Jude Medical Tendril MRI LPA1200M
Summary of Contents for St. Jude Medical Tendril MRI LPA1200M
- Page 1 Tendril MRI ™ Pacing leads Model LPA1200M User's Manual...
- Page 2 State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.
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Page 3: Indications And Usage
MR Conditional lead is part of the St. Jude Medical MR Conditional system. Patients with an implanted St. Jude Medical MR Conditional system can have an MRI scan if the conditions for use, as described in the MRI-Ready Systems Manual, are met. -
Page 4: Storage And Handling
MRI-Ready Systems Manual. Scanning under other conditions may result in severe patient injury or death. The St. Jude Medical MR Conditional system includes a St. Jude Medical MR Conditional pulse generator connected to one or more St. Jude Medical MR Conditional leads. -
Page 5: Adverse Events
Adverse Events The Reported Adverse Events (page 3) summarize the adverse events in the Accent MRI ™ ™ Pacemaker and Tendril MRI Lead Investigational Device Exemption Study (MRI Study). The MRI study was a prospective, multi-center clinical investigation designed to evaluate the safety and efficacy of the Accent MRI pacemaker system in a patient population indicated for implant of a pacemaker within and outside of an MRI environment. - Page 6 Table 1. MRI study adverse events Event Description # of % of #AEs AE/pt-years Patients Patients (n=1,535.44 with with AEs yrs) (n=920) Hemothorax 0.11% 0.001 Infection 0.54% 0.003 Lead dislodgement or migration - RA Lead 2.61% 0.016 Lead dislodgement or migration - RV Lead 0.76% 0.005 Lead fracture...
- Page 7 Table 1. MRI study adverse events Event Description # of % of #AEs AE/pt-years Patients Patients (n=1,535.44 with with AEs yrs) (n=920) Pacemaker mediated tachycardia (PMT) 2.17% 0.014 Pain at device site 0.11% 0.001 Pectoral stimulation 0.11% 0.001 Pericardial effusion 0.43% 0.003 Pericarditis...
- Page 8 Table 2. MRI study events not adjudicated as either observations or complications ORE Description # of Patients # of Events Comments Arrest – Respiratory Patient aspirated on an ice chip and went into respiratory failure ultimately resulting in patient death. Asystole Patient suffered an acute MI at home and expired...
- Page 9 Table 2. MRI study events not adjudicated as either observations or complications ORE Description # of Patients # of Events Comments Mitral Stenosis MVR with single vessel CABG. Nausea & Generalized Patient withdrew from study due to other Weakness underlying medical conditions unrelated to study device/procedures.
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Page 10: Potential Adverse Events
A summary of the Events committee death classifications is shown in the table below. Table 3. Events committee classification of patients deaths Primary Cause Number of Patients Cardiac: Arrhythmic Cardiac: Ischemic Cardiac: Pump Failure Cardiac: Unknown Non-Cardiac Unknown TOTAL Potential Adverse Events Possible adverse events associated with the system, include, but are not limited to the following: MRI system adverse events: Lead electrode heating and tissue damage resulting in loss of sensing or capture or both... -
Page 11: Summary Of Clinical Study
electromyogenic or electromagnetic Loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface Loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation) Lead malfunction due to conductor fracture or insulation degradation ... - Page 12 parameter set incorporated in the Accent MRI pacemakers. In addition, all other device components which could have an impact on compatibility with the magnetic resonance environment are unchanged from the Accent MRI pacemaker; therefore all Accent MRI endpoint data collected during the study that provided reasonable assurance of safety and effectiveness within and outside of an MRI environment is applicable to the Assurity MRI and Endurity MRI devices.
- Page 13 Figure 1. Lead Safety Phase The figure below depicts the MRI Phase.
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Page 14: Study Objectives
Figure 2. MRI Phase Study Objectives The objective of this clinical study was to verify the safety and efficacy of the ™ Accent MRI pacemaker system indicated for implant of a pacemaker within and outside of the MRI environment. Primary Objectives The following are the primary safety and efficacy objectives defined for this study. - Page 15 Lead Safety ™ Safety of the Tendril MRI lead was evaluated in terms of freedom from RA and RV lead-related complications for the acute (implant to two-month visit) and chronic (two-month visit through the 12 month visit) time frames. MRI Safety The safety of the Accent MRI system was evaluated in terms of freedom from MRI scan-related complications in the month following the MRI scan.
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Page 16: Patient Population
Was unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore. Had a prosthetic tricuspid heart valve. Was currently participating in a clinical investigation that includes an active treatment arm. Was allergic to dexamethasone sodium phosphate (DSP). Was pregnant or planning to become pregnant during the duration of the study. -
Page 17: Demographic Data
Figure 3. Number of patients attempted and implanted with the Accent MRI pacemaker and Tendril MRI lead The figure below displays the number of patients who contributed data to the MRI phase. Figure 4. Number of patients participating in MRI phase/contributing scan data As of October 30, 2014, the total time of follow-up from the time of successful implant was 18,425 patient-months. - Page 18 thereafter, during which the following tests/assessments were performed: electrical measurements on the RA and/or RV leads. Patients were also assessed for adverse events at all study visits. For the MRI Phase of the study, patients completed an MRI Visit, and returned approximately thirty days later for a one-month post-MRI visit.
- Page 19 Table 4. Summary of demographic variables for all enrolled patients Demographic Variable All Enrolled Patients (N = 920) Primary Indication for Device Implant, n (%) AV Block 244 (26.5%) Pacemaker Generator Change 2 (0.2%) Prevention/Termination of 13 (1.4%) Tachyarrhythmias By Pacing Sinus Node Dysfunction 581 (63.2%) Syncope...
- Page 20 Table 5. Summary of demographic variables for all patients contributing data to the MRI phase Demographic Variable Patients Enrolled Patients Total (N = 255) in the MRI Study Contributing (N = 225) Supplemental MRI Scan Data (N = 30) Permanent 15 (15.3%) 1 (5.0%) 16 (13.6%)
- Page 21 RV Lead-Related Complications (2 month through 12 month visit) Nine hundred two (902) patients who had a Tendril MRI ™ lead attempted or successfully implanted and who were not withdrawn before the two-month visit were analyzed for this endpoint. No RV lead-related complications were observed. The probability of RV lead-related complication-free survival at the 12-month follow-up visit was calculated as 100% with a 95% lower confidence bound of 100%, which is greater than the objective performance criterion of 95%.
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Page 22: Conformance To Standards
Secondary Endpoint Results System-Related Complications Nine hundred twenty (920) patients who had an Accent MRI ™ pacemaker system attempted or successfully implanted were analyzed for this endpoint. Forty-five (45) system-related complications (RA lead, RV lead, pacemaker- and system-related complications) were observed. The probability of system-related, complication-free survival at the 12-month follow-up visit was calculated as 94.64% with a 95% lower confidence bound of 92.76%, which is greater than the objective performance criterion of 80%. -
Page 23: How Supplied
Removing and Inserting the Stylet To remove a stylet from the fixation tool, unscrew the proximal thumbscrew on the tool by turning it counter-clockwise and withdraw the stylet. For additional information, contact your St. Jude Medical Sales Representative. - Page 24 Figure 5. Unscrew the proximal thumbscrew on the fixation tool before you withdraw the stylet To insert a stylet into the fixation tool, attach the terminal lead pin into the distal (gray) portion of the tool, then insert the stylet through the proximal (white) portion. The stylet should be inserted into the lead before the lead is inserted into the vein.
- Page 25 Figure 7. Extend the helix by rotating the fixation tool clockwise Retract the helix by holding the lead body stationary in one hand and turning only the gray portion of the tool opposite the direction indicated by the arrow "FIXATE" (counterclockwise). Figure 8.
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Page 26: Position The Lead
Figure 9. Vein lifter Using the Lead Introducer If a lead introducer is used, follow the instructions provided with the introducer. CAUTION: If using a percutaneous lead introducer with a hemostasis valve, make sure the valve allows for appropriate passage of the lead without damaging the lead body. - Page 27 When the lead is past the appendage and in the chamber, feed more lead into the heart so that it regains its "J" shape. Take a firm grip on the stylet, then introduce more of the lead so that the electrode tip goes as far as possible into the atrium.
- Page 28 Figure 10. Open the clip-on tool 1. Insert lead into notch...
- Page 29 Figure 11. Extend the helix by rotating the clip-on tool clockwise Secure the Tip with the Fixation Tool As an alternative to the clip-on tool, the fixation tool may be used to extend or retract the helix. After the fixation site has been selected, hold the lead body stationary in one hand and turn the distal (gray) portion of the fixation tool in the direction marked "FIXATE"...
- Page 30 withdraw the stylet under fluoroscopic observation. The lead tip should remain in position. Exercise caution during stylet retraction to avoid dislodging the lead. Retraction of the J-shaped stylet may be more difficult than retraction of a straight stylet. A recommended method for retracting a J-shaped stylet is to loosen the proximal thumbscrew and hold the stylet handle manually;...
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Page 31: Connection To The Device
Figure 13. Suture the lead 1. Vein 2. Fascia 3. Lead body CAUTION: Use the suture sleeve to distribute the tension created by the suture. Failure to use the suture sleeve may result in damage to the lead's insulation or conductor coil. -
Page 32: Sterilization Instructions
Out-of-Service/Explant/Patient Death Form Return all extracted leads, whether intact or not, and all unused leads, to St. Jude Medical for investigation. Complete an Out of Service/Explant/Patient Death form and return it to St. Jude Medical with the extracted leads. -
Page 33: Technical Specifications
Straight stylet 6-10 J-stylet 8-11 St. Jude Medical IS-1 lead connectors are compatible with connector cavities that conform to the international connector standard ISO 5841-3. MP35N is a trademark of SPS Technologies. Not to exceed 20 rotations. Lead length, stylet configuration, and differences in anatomy may cause variations in the number of rotations required to extend... -
Page 34: Stylet Color Codes
Accessories Some accessories are not necessarily packaged with the lead and may be ordered separately. For more information, contact your local St. Jude Medical representative. Table 9. Accessories Lead cap Vein pick Suture sleeve Stylet Kit with Clip-On Tool Stylet Kit with Fixation Tool Locator ™... - Page 38 St. Jude Medical St. Jude Medical Coordination Center BVBA Cardiac Rhythm The Corporate Village Management Division Da Vincilaan 11 Box F1 15900 Valley View Court 1935 Zaventem Sylmar, CA 91342 USA Belgium +1 818 362 6822 +32 2 774 68 11 sjm.com...