Sulzer Pacemakers

3/13/97 Sulzer Intermedics Marathon SR & DR Pacemakers 3300 units RX 5000 Software Operating System

A software condition caused the parameters of the 2 pacemakers to become reversed. That is, the software cannot distinguish Marathon DR (dual chamber) from Marathon SR (single-chamber) USER PRESET values; whichever values were most recently stored will be recalled.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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