Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had an ins replacement.During the replacement, high impedances were discovered when connected to the new ins.Impedances were over 10,000 on all contacts.It is not known if any external or environmental factors contributed to this event.The patient is alive no injury.
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Concomitant medical products: product id 977a260, serial# (b)(6), implanted: (b)(6) 2015, product type: lead, product id: 977a260, serial# (b)(6), implanted: (b)(6) 2015, product type: lead.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.
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Additional information was received from a manufacturer representative regarding the patient.It was reported that the cause of the high impedances was unknown.Programs were set up on the functioning lead.The patient is trying to determine if she is getting effective stimulation.If the patient is not getting effective stimulation, the physician will do a lead revision at a later date; however, that date is unknown.The physician does not know any further information regarding this event.There were no further complications reported.
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