It was reported that the patient underwent a dbs implant surgery on (b)(6) 2020.During the surgery, the surgeon found that blood had penetrated inside the lead and could not be used normally, the lead was replaced and the issue was resolved.The patient was in good condition.
|
H3: the returned lead was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Upon receipt, visual inspection noted fluid consistent with body fluids in the lead.Each conductor is individually insulated so there was no impact on the lead or lead performance.Electrical testing determined that continuity was complete and there were no electrical shorts between the circuits.H6: device code c63018 was added in error.Method code 10 has replaced 4114.Result code 213 has replaced 3221.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|