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On September 22, Guidant issued safety advisories and recalls for 170,000 of their pacemakers, 56% of their total pacemakers. On October 18, Johnson & Johnson gave an announcement that they were exploring alternatives to the acquisition, followed by a November 2 warning that they might pull out of the deal due to the regulatory issues and legal ...
The cause of the recall was a "J lead" electrode, utilizing a rigid stylet within the helix of the electrode lead, inherited by the company in acquisition of pacemaker lead manufacturer Cordis Corporation of Miami. The inherent dangers arising from incorporation of a rigid stylet had been demonstrated by Telectronics, Sydney, in 1967.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
“A pacemaker is an implanted device that (tracks) the patient’s heart rate, and when it senses the heart rate below a certain programmable number — that’s usually either 50 or 60 — then ...
Information regarding product labels and the list of products will be provided when available. "The products subject to recall bear establishment numbers '51205 or P-51205' inside or under the ...
Pacemaker failure is the inability of an implanted artificial pacemaker to perform its intended function of regulating the beating of the heart. A pacemaker uses electrical impulses delivered by electrodes in order to contract the heart muscles. [ 1 ]
The California-based medical device maker, which started the recall process on Nov. 20, said the classification was due to a correction in the labeling and is not a product removal. The FDA ...
[17] [18] [19] The name pacemaker syndrome was first coined by Erbel in 1979. [18] [20] Since its first discovery, there have been many definitions of pacemaker syndrome, and the understanding of the cause of pacemaker syndrome is still under investigation. In a general sense, pacemaker syndrome can be defined as the symptoms associated with ...
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