Published studies based on FDA and non-FDA data have documented implanted pacemaker and ICD device failures, several thousands advisories, and an increasing rate of recall. Dominant failure modes have been identified to include capacitor, connector, and electrical anomalies. Currently, built-in self test methods diagnose failure based on reactive fault-detection. Assessing the system-level damage-state and residual-life beyond the state-of-art because of variations in environmental conditions and personal usage patterns. Usage factors that can impact the life of a medical system, include, programmed parameter factor variations in the rate, amplitude, pulse width, shock energy, and mode (number of chambers paced); patient factors such as unique therapy needs (shock frequency, percent paced), lead impedances, and pacing/shocking thresholds. The proposed detection of early indicators of system degradation can signal impending failure and help impact system replacement before failure.
Broader Impact The proposed effort has the potential for broad impact in implantable medical devices, pacemakers for treating conduction disorders such as bradycardia; defibrillators to treat ventricular and atrial tachyarrhythmia and fibrillation; muscle stimulators to treat urinary incontinence, fecal incontinence, and gastroparesis; neurological stimulators to treat Parkinson's disease; cochlear implants to treat hearing disorders; drug pumps for pain management. The broader impact and outreach activities will include: (a) Initiation of undergraduate students, women and under-represented minorities in research; (b) Partnership with the Women's Leadership Institute at Auburn University; (c) Organization of a topical-session at the ASME Congress (IMECE); (d) Technology transfer to leading manufacturers including Medtronic; (f) Introduction of K-12 school children to biological electronics through lab tours and in-class presentations.
