Poor tracking provokes consent decree at Telectronics:
This article was originally published in Clinica
Executive Summary
Ineffective tracking by Telectronics (US) has prompted the FDA to block sales and manufacture of leads. The troubled pacemaker company cannot resume operations until a proper system for monitoring the safety of its implantable pacemaker products has been approved by an external auditor. The FDA consent decree follows warning letters sent to the company last October. It does not affect exports or leads already shipped to distributors.