On (b)(6) 2023 (b)(4) (con): it was reported that in (b)(6) of last year the patient's barber noticed that there was a bulge on top of the patient's scalp and they could see a little piece of wire that the caller described as a "loop of wire" coming out of the patient's scalp.Agent did not ask about the circumstances that led to the reported event.The healthcare provider (hcp) was afraid the patient might develop an infection that could potentially spread to their chest, so they decided to explant the lead that was sticking out of the patient's scalp.The caller noted that the lead was not replaced, and they said the patient managed themselves fine with the remaining lead. the caller mentioned relevant medical history which included that the dbs therapy made a big difference in the patient's life.
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Section d information references the main component of the system.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(6), ubd: 03-sep-2011, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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