Perspective:

Postmarket medical device safety surveillance is essential for patient safety, yet it is carried out with an inconsistent mix of mandatory and voluntary adverse event reporting systems. The existing systems are compromised by under-reporting and a lack of information on the total number of devices implanted. The current study offers an example of a ‘prospective’ automated surveillance tool allowing for near ‘real-time’ postmarket surveillance with the use of a clinical database. The advantage of this approach is its ability to identify low-frequency safety signals early; however, its robustness depends on an a priori prespecification of sensitivity, subgroup, and secondary endpoint analysis. In addition to potentially revealing safety issues intrinsic to the device in question, this approach may allow monitoring of operator-dependent complications. In a nutshell, the authors present a model for merging post-market safety surveillance with quality improvement initiatives in a single platform, something very desirable in value-based provision of care. A similar surveillance system might have alerted us to the excessive rates of Sprint Fidelis and Riata implantable cardioverter-defibrillator lead failures, before they were implanted in hundreds of thousands of patients.