Abstract: A method and medical device for monitoring patient medication compliance having a plurality of electrodes to deliver a pacing therapy, and a processor configured to determine a pacing threshold in response to the delivered pacing therapy, determine whether there is a change in the pacing threshold, determine, in response to a change in the pacing threshold determined to be occurring, whether the determined change is sustained, and determine patient medication compliance in response determining whether the determined change is sustained.

Abstract: A fixation member of an electrode assembly for an implantable medical device includes a tissue engaging portion extending along a circular path, between a piercing distal tip thereof and a fixed end of the member. The circular path extends around a longitudinal axis of the assembly. A helical structure of the assembly, which includes an electrode surface formed thereon and a piercing distal tip, also extends around the longitudinal axis and is located within a perimeter of the circular path. The tissue engaging portion of the fixation member extends from the distal tip thereof in a direction along the circular path that is the same as that in which the helical structure extends from the distal tip thereof. The electrode assembly may include a pair of the fixation members, wherein each tissue engaging portion may extend approximately one half turn along the circular path.

Abstract: A method and medical device for monitoring cardiac function in a patient that includes a plurality of electrodes to deliver cardiac pacing therapy, and a processor configured to determine a pacing threshold in response to initial delivery of the pacing therapy, determine whether there is a change in the pacing threshold during initial delivery of the pacing therapy, adjust a delivery parameter of the pacing therapy in response to determining the change in the pacing threshold during initial delivery of the pacing therapy, determine whether there is an increase in the pacing threshold during delivery of the adjusted pacing therapy, and determine hypokalemia in response to the increase in the pacing threshold during delivery of the adjusted pacing therapy being present.

Abstract: A method and medical device for monitoring cardiac function in a patient that includes a plurality of electrodes to deliver cardiac pacing therapy, and a processor configured to determine a pacing threshold in response to initial delivery of the pacing therapy, determine whether there is a change in the pacing threshold during initial delivery of the pacing therapy, adjust a delivery parameter of the pacing therapy in response to determining whether there is a change in the pacing threshold during initial delivery of the pacing therapy, determine whether there is a decrease in the pacing threshold during delivery of the adjusted pacing therapy, and determine hyperkalemia in response to the decrease in the pacing threshold during delivery of the adjusted pacing therapy being present.

Abstract: A fixation member of an electrode assembly for an implantable medical device includes a tissue engaging portion extending along a circular path, between a piercing distal tip thereof and a fixed end of the member. The circular path extends around a longitudinal axis of the assembly. A helical structure of the assembly, which includes an electrode surface formed thereon and a piercing distal tip, also extends around the longitudinal axis and is located within a perimeter of the circular path. The tissue engaging portion of the fixation member extends from the distal tip thereof in a direction along the circular path that is the same as that in which the helical structure extends from the distal tip thereof. The electrode assembly may include a pair of the fixation members, wherein each tissue engaging portion may extend approximately one half turn along the circular path.

Abstract: Substernal implantable cardioveter-defibrillator (ICD) systems and methods for providing substernal electrical stimulation therapy to treat malignant tachyarrhythmia, e.g., ventricular tachycardia (VT) and ventricular fibrillation (VF) are described. In one example, an implantable cardioveter-defibrillator (ICD) system includes an ICD implanted in a patient and an implantable medical electrical lead. The lead includes an elongated lead body having a proximal end and a distal portion, a connector at the proximal end of the lead body configured to couple to the ICD, and one or more electrodes along the distal portion of the elongated lead body. The distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the ICD is configured to deliver electrical stimulation to a heart of the patient using the one or more electrodes.

Abstract: An implantable cardiac defibrillator (ICD) system includes an ICD implanted subcutaneously in a patient, a defibrillation lead having a proximal portion coupled to the ICD and a distal portion having a defibrillation electrode configured to deliver a defibrillation or cardioversion shock to a heart of the patient, and a pacing lead that includes a distal portion having one or more electrodes and a proximal portion coupled to the ICD. The distal portion of the pacing lead is implanted at least partially along a posterior side of a sternum of the patient within the anterior mediastinum. The ICD is configured to provide pacing pulses to the heart of the patient via the pacing lead and provide defibrillation shocks to the patient via the defibrillation lead. As such, the implantable cardiac system provides pacing from the substernal space for an extravascular ICD system.

Abstract: Techniques and methods for determining the number and type of leads that are connected to an implantable medical device (IMD) system are disclosed. The IMD system is configured having at least two modes of operation, the modes of operation corresponding to the number and type of leads that are coupled to the IMD system. In accordance with aspects of the disclosure, one of the at least two modes may be selected based on the determination of the number and type of leads that are connected to the IMD system.

Abstract: Devices and implantation methods utilizing subcutaneous placement into a patient are disclosed for the insertion, advancement and positioning of a subcutaneous implantable medical device (SIMD) such as a medical electrical lead. The device for implanting the SIMD is configured having a pre-biased distal curve for creating a pathway to an implant location within a substernal space.

Abstract: Implantable leadless cardiac pacing systems and methods for providing substernal pacing using the leadless cardiac pacing systems are described. In one embodiment, an implantable leadless cardiac pacing system includes a housing, a first electrode on the housing, a second electrode on the housing, and a pulse generator within the housing and electrically coupled to the first electrode and the second electrode. The housing is implanted substantially within an anterior mediastinum of a patient and the pulse generator is configured to deliver pacing pulses to a heart of the patient via a therapy vector formed between the first and second electrodes.

Abstract: Implantable cardiac pacing systems and methods for providing substernal pacing are described. In one example, a cardiac pacing system includes a pacemaker implanted in a patient and an implantable medical electrical lead. The implantable medical electrical lead includes an elongated lead body having a proximal end and a distal portion, a connector configured to couple to the pacemaker at the proximal end of the elongated lead body, and one or more electrodes along the distal portion of the elongated lead body, wherein the distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the pacemaker is configured to deliver pacing pulses to a heart of the patient.

Abstract: Implantable cardiac systems and methods for providing substernal pacing in an ICD system are described. In one example, an implantable cardiac system comprises an ICD system and an implantable leadless pacing device (LPD) communicatively coupled to the ICD system. The ICD system includes an ICD and an implantable defibrillation lead having a proximal portion coupled to the ICD and a distal portion having a defibrillation electrode configured to deliver a defibrillation shock to a heart of the patient. The LPD includes a housing, a first electrode on the housing, a second electrode on the housing, and a pulse generator within the housing and electrically coupled to the first electrode and the second electrode. The housing of the LPD is implanted substantially within an anterior mediastinum of the patient and the pulse generator is configured to deliver pacing pulses to a heart via the first and second electrodes.

Abstract: A fixation member of an electrode assembly for an implantable medical device includes a tissue engaging portion extending along a circular path, between a piercing distal tip thereof and a fixed end of the member. The circular path extends around a longitudinal axis of the assembly. A helical structure of the assembly, which includes an electrode surface formed thereon and a piercing distal tip, also extends around the longitudinal axis and is located within a perimeter of the circular path. The tissue engaging portion of the fixation member extends from the distal tip thereof in a direction along the circular path that is the same as that in which the helical structure extends from the distal tip thereof. The electrode assembly may include a pair of the fixation members, wherein each tissue engaging portion may extend approximately one half turn along the circular path.

Abstract: A delivery catheter includes a pre-formed and resilient heart-wrapping segment. The segment may have a relaxed span that allows the segment to wrap around a left side of a heart from an anterior epicardial surface to a posterior epicardial surface, when the catheter is advanced along the epicardial surface, having been inserted from a sub-xiphoid access site.

Abstract: A system for monitoring trends in lead impedance includes collecting data from various sources in an implantable medical device system. Lead impedance, non-physiologic sensed events percentage of time in mode switch, results of capture management operation, sensed events, adversion pace counts, refractory sense counts and similar data are used to determine the status of a lead. A set of weighted sum rules are implemented by a software system to process the data and provide displayable information to health care professionals via a programmer. The lead monitoring system includes a patient alert system for patients to seek help in the event a serious lead condition is identified.

Abstract: A system for monitoring trends in lead impedance includes collecting data from various sources in an implantable medical device system. Lead impedance, non-physiologic sensed events percentage of time in mode switch, results of capture management operation, sensed events, adversion pace counts, refractory sense counts and similar data are used to determine the status of a lead. A set of weighted sum rules are implemented by a software system to process the data and provide displayable information to health care professionals via a programmer. The lead monitoring system includes a patient alert system for patients to seek help in the event a serious lead condition is identified.

Abstract: An implantable electrical medical device and method for manufacturing the same are provided. The method includes forming a conductive substrate, placing the conductive substrate in a deposition chamber; and forming a conformal coating over the conductive substrate using atomic layer deposition. In various embodiments, the conformal coating is a conductive coating and in other embodiments the conformal coating is a dielectric coating.

Abstract: A method for manufacturing an implantable electrical medical device includes forming a conductive substrate, placing the conductive substrate in a deposition chamber; and forming a conformal coating over the conductive substrate using atomic layer deposition. In various embodiments, the conformal coating is a conductive coating and in other embodiments the conformal coating is a dielectric coating.

Abstract: An implantable medical device (IMD) includes a lead status monitoring system. The lead status monitoring system employs a method including the steps of: collecting data sets from a lead impedance source, a stimulation threshold source, and at least one additional source included in the IMD; and processing the data sets to determine if a lead status event has occurred.

Abstract: A delivery catheter includes a pre-formed and resilient heart-wrapping segment. The segment may have a relaxed span that allows the segment to wrap around a left side of a heart from an anterior epicardial surface to a posterior epicardial surface, when the catheter is advanced along the epicardial surface, having been inserted from a sub-xiphoid access site.