The case report of an “exploding” ICD, originally published and then withdrawn in the journal Europace, continues to provoke comment and controversy.
On Friday evening, Westby Fisher, the electrophysiologist and blogger who first drew attention to the Europace report, met with officials from Biotronik and later summarized the meeting on his blog.
The Biotronik officials shed some additional light– and perhaps raised some additional questions– on the episode. With the permission of the company Fisher reprints a PDF of the internal Biotronik memo that appears to provide the fullest chronology of the episode so far.
The memo establishes a number of significant facts:
- The episode occurred on May 12, 2010 in the Slovak Republic and was reported to the FDA on May 19. An update with the company’s analysis of the episode was submitted to the FDA on June 7, 2010.
- The company believes this to be a “singular event” that won’t results in a recall and that the company will not issue a “Dear Doctor” letter .
- This is the first time an event like this has occurred in a Biotronik device, but “sudden discharges of battery energy, commonly referred to as “hot pocket” have previously (but rarely) been reported in the CRM industry,” the memo states.
The company is less helpful in its explanation for the withdrawal of the Europace article. Here is what the memo states:
Why was the case report withdrawn?
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.
When was the case report withdrawn from Europace online?
The case report was voluntarily withdrawn by the physician-author, Dr Martin Hudec, on October 5, 2010. On October 6, 2010, the case report was removed from the Europace website.
Although Biotronik has an obvious and legitimate interest in the publication of the case report, the company’s role in the publication (or depublication) process appears questionable. The two “inaccuracies” noted in the memo– the use of the word “explosion” and the fact that batteries in other devices have overheated in the past– don’t seem to warrant withdrawal of the publication from an independent, academic journal without any explanation or notification from the editor. Wouldn’t a brief correction have sufficed? One can certainly see how from a public relations point of view the disappearance of the article would be of value to Biotronik. It is less clear how the withdrawal serves the editorial purpose of an academic journal like Europace.