Friday evening, I met with Rex Richmond (Vice President of Marketing) and Dan Schlewitz (Executive Vice President U.S.A. Sales) from Biotronik, Inc. to hear their side of the controversy surrounding the withdrawal of a case report previously published in Europace pertaining to an “exploding” Biotronik implantable cardiac defibrillator (ICD). They claimed they have been transparent regarding the reporting of this incident to the FDA, filing their incident report with the FDA within seven days of the event (within thirty days is required). Mr. Richmond granted me permission to release their internal company memo (pdf) circulated to their employees regarding the case report.
I must supply several comments.
First, regarding why the case report was withdrawn, they state in their memo:
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The author reported that after submitting the case report to Europace in June, further analysis was conducted but not included in the original report. As such, there are inaccuracies that need to be corrected. Specifically, the author stated that the term “explosion” was not accurate given that the device was distorted, but had not exploded as previously described. The author also observed that while this is the first such incident with a BIOTRONIK device, it is not in fact the first experience of a battery overheating in the industry.
Note that the updated MDA was submitted to the FDA 6 June 2010. The published article was submitted to Europace 29 June 2010 and accepted after revision 16 August 2010. Wouldn’t these “inaccuracies” have been corrected with the revisions submitted back to Europace following their review well before the 27 Sep 2010 publishing date?
Second is the issue of FDA reporting mentioned in the memo:
Where do reports like this end up? Aren’t they public?
Yes, they do become public. The FDA posts MDR’s to their online Manufacturer and User Facility Device Experience (MAUDE) database at the following address:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
(ed: Emphasis mine) Although the FDA has our MDR, it has yet to be posted to the database.
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I do not know why the FDA would not have published the MDA’s received in May with revisions in June on their website by 31 August 2010 (August data appear to have the latest updates available online) if the original MDA was submitted in May as Biotronik suggests. Does it really take this long to review MDA’s before they are published? It is one thing to verify an MDA from the public before publishing on the FDA MAUDE database, but a manufacturer’s MDA regarding their own device should be published without delay.
Reference: pdf of my personal copy of withdrawn Europace case report obtained online 5 Oct 2010 before its withdrawal with timeline of the article’s submission/revision dates.
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005. He writes regularly at Dr. Wes. DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.
