A company-initiated recall of 2 designs of SYMBOL S-ICD (Boston Scientific) subcutaneous implantable cardioverter defibrillator pulse generators has actually been classified as Class I by the United States Food as well as Drug Administration (FDA), the firm revealed today.
The FDA notes that the advising, which was connected to individuals as well as physicians in December, uses to 2825 of the business’s S-ICD design A209 as well as MRI S-ICD A219 tools, which were dispersed from June to September 2019. The factor: “A manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high voltage shocks. If this happens during use, patients may experience less shock than intended or may not receive a shock at all,” the firm states.
“The manufacturer has received six complaints about this device issue. There have been no reports of injuries or deaths,” it claims.
The news advises a remote or in-office system examine every 3 months for individuals that have actually currently been dental implanted with these tools, plus normal follow-up with the Boston Scientific LATITUDE remote tracking network.
The FDA recall news is a follow up to one it made in very early February that designated Class I to a company-initiated recall of SYMBOL S-ICD leads due to a noticeable increased risk for crack. There had actually been 27 records of significant injuries, consisting of fatality in one instance, in organization with the lead trouble, the firm kept in mind.
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