I wrote recently about a blogger that reported about an exploding ICD and then ended up retracting his story for “defensive blogging”, what ever that means. Here is a follow up article about that story.
‘Explosive’ Case Study on Again at Pacing Journal
By Michael Smith, North American Correspondent, MedPage Today
A controversial article about problems with an implanted cardiac device — published by and then withdrawn from the journal Europace — has been resubmitted and is under review, according to the journal’s editor.
“I expect that a decision on publication will be made very shortly,” John Camm, MD, of St. George’s University of London, told MedPage Today in an e-mail.
The article — entitled “Spontaneous explosion of implantable cardioverter-defibrillator” and originally published on Sept. 27 — described the effects of a malfunctioning Biotronik Lumax 340 VR-T device that had been implanted in a 46-year-old patient with a medical history that included permanent atrial fibrillation, dilated cardiomyopathy, and chronic heart failure.
Controversy arose when the piece was swiftly withdrawn by the lead author, Martin Hudec, MD, of the Middle-Slovak Institute of Cardiovascular Diseases in Banska Bystrica, Slovakia.
The now-you-see-it, now-you-don’t article was first reported by blogger Westby Fisher, MD, a cardiac electrophysiologist at NorthShore University HealthSystem in Evanston, Ill. His blog, Dr. Wes, is also carried by MedPage Today.
Fisher’s original post, which included some of the pictures of the patient’s injuries, also did a disappearing act, which Fisher described as “defensive blogging.” He told readers the impact of the pictures of what is a very rare event might have “compromising” ramifications for the medical device industry and for him.
Fisher told MedPage Today in an e-mail that he was not under any pressure from the manufacturer of the device, Biotronik of Berlin, or from the journal. He was mainly worried, he said, about copyright issues.
Hudec also told MedPage Today in an e-mail that there was no pressure from Biotronik to withdraw the article. “I was not under any pressure from (the) manufacturer at all,” he said. Indeed, he went on, Biotronik “was very helpful to provide all detailed information on technical aspects of the issue.”
For one thing, Hudec said, the term “explosion” was not accurate; it was actually venting of the battery. Also, he said, although he and his colleagues had not found other cases that occurred outside the hospital setting when they searched the literature online, 10 have been reported to the FDA’s Manufacturer and User Facility Device Experience database.
Indeed, although the Slovakian case may still be the first to report a failure outside a clinical setting, it is not the first in the literature. In 2001, a physician at Boston’s Brigham and Women’s Hospital reported in the Journal of Cardiovascular Electrophysiology that a pectoral implantable cardioverter defibrillator (ICD) — in a 79-year-old patient — failed under periodic defibrillation threshold testing 18 months after implant.
The failure was accompanied by “a light flash above the pocket and a loud ‘pop,’ ” according to the report.
That description was similar to the one given by Hudec and his co-author, who wrote in the original article that their patient was admitted to emergency two weeks after the implant “due to the ICD exploding in situ, described by the patient as a loud ‘pop.’ ”
The patient had a “grey-yellow necrotic area with surrounding erythema” over the ICD. Clinicians also observed “palpable subcutaneous emphysema bilaterally extending into the neck, throughout the left thoracic wall,” and down the left arm. When the device was removed, it was deformed and had burnt necrotic tissue on its surface.
Hudec and his co-author said that the apparent cause, determined by the manufacturer, was overheating of the battery, which caused an increase in internal pressure.
A spokesman for the company told MedPage Today that “Biotronic did not pressure either the author or the publication to withdraw the original case study.”
Rex Richmond, the company’s vice president of marketing and communications, said in an e-mail that the company “fully understands and honors the peer review process and does not seek to interfere with it in any way.”
In an internal memo, posted by Fisher with the company’s permission, Biotronik said the incident — reported to the FDA on May 19, 2010 with an update analysis submitted June 7 — was a “singular event of no systemic nature.”
The company also said it was the first time such an event had occurred with one of its products, but noted that sudden battery discharges have been reported in connection with devices made by others.
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