Manufacturer Ignores Signals About Failing Heart Implant, Patients Not Informed
3 Articles
3 Articles
For over ten years, cardiologists worldwide have been warning of an increased risk of broken wires from manufacturer Biotronik attached to special heart monitors. Yet the manufacturer and the inspectorate never intervened. In the Netherlands, over a thousand people still have these wires.
Doctors from all over the world have been encountering problems with the leads of implantable defibrillators for years. Biotronik, the German manufacturer of the leads, dismisses all accusations, and the inspectorate meekly follows suit. The heart patients themselves? They are told nothing.
For ten years, doctors worldwide have been encountering problems with Biotronik defibrillator wires. The company denies all accusations, and the regulatory body meekly follows the manufacturer in this.
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