Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7101836.Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7103295.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7106574.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7113613.
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It was reported the patient experienced redness and swelling at the chest incision, and the incision made to connect the extensions to the leads.Cultures were taken, but results were not released by the physician.The patient underwent an explant procedure where the entire deep brain stimulation (dbs) system was removed.Physical analysis of the explanted devices could not be performed in our laboratory, as the devices were sent out for cultures by the facility and were not returned.
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