Medical device tracking: Results of a case study of the implantable cardioverter defibrillator

Case reports were received of a fatal tachycardia caused by a malfunction o f an implantable cardioverter defibrillator (ICD), a device that is subject to the tracking regulations of the Food and Drug Administration's Center f or Devices and Radiological Health. The case reports led to a decision to n otify 5,604 patients of the need for reprogramming of their ICDs to prevent the tachycardia. In the first 60 days, a total of 98.7% of the patients we re successfully located and their devices reprogrammed. Multiple logistic r egression analysis wets conducted to examine an extensive array of factors that might have been related to the time to reprogramming. Patient-specific factors such as age, sex, and ejection fraction did not serve as a barrier to reprogramming in the first week (p = NS). patients whose regular physic ian had >5 patients with the ICD subject to the recall were significantly m ore likely to have their ICDs reprogrammed in the first week (odds ratio [O R] 2.11, 95% confidence interval [CI] 1.85 to 2.43, p <0.001). Patients who changed physicians were significantly less likely to undergo reprogramming in the first week (OR 0.73, 95% CI 0.63 to 0.86, p <0.001). The experience of the recall of this tracked device is highly encouraging because it demo nstrates that most tracked device recipients can be successfully located an d receive medical intervention. Although tracking devices is a manufacturer 's responsibility, the clinical community plays a critical role in its succ ess. This report highlights the importance of understanding that role among physicians. (C)2000 by Excerpta Medico, Inc.