I must supply several comments.
First, regarding why the case report was withdrawn, they state in their memo:
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?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.
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:
(ed: Emphasis mine) Although the FDA has our MDR, it has yet to be posted to the database.
Reference: pdf of my personal copy of withdrawn Europace case report obtained online 5 Oct 2010 before its withdrawl with timeline of the article's submission/revision dates.
CORRECTION - 12:55pm CST 12 Oct 2010: Here's a link to the FDA report regarding this incident filed on the FDA's MAUDE database. I apologize for the inaccuracy.
Addendum 09:45 AM CST 12 Oct 2010 - Reactions from around the web:
Cardiobrief: "The Plot Thickens in the Case of the Exploding ICD"
Happy Hospitalist: "Exploding ICD Gets Biotronik Response"