Model Number NEU_ENTERRA_INS |
Device Problems
High impedance (1291); Low impedance (2285)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 06/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 4351.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the patient was seen on (b)(6) 2018, and had been doing really well with their new ins battery which was replaced around a year prior.Over the previous six weeks though, the patient felt that things were deteriorating and they were struggling to tolerate more than supplements.This was unusual for the patient.The hcp checked the patient's ins and was unable to make any adjustments as the impedance was very high.It was noted that this was potentially related to electrode dislodgement and the hcp organized a plan to x-ray and see if there was any obvious damage or displacement of the electrodes, and to do endoscopy to look for any signs of intra-gastric erosion.The hcp was to see the patient with result of this in due course.Impedance readings were: 1+c = 531 ohms, 2+c = 566 ohms, 3+c = 471 ohms, 1+2 = less than 50 ohms, 1+3 = 928 ohms, 2+3 = 928 ohms.The cause of the impedance issues was not determined.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the hcp via the manufacturer representative.It was reported that the x-ray and endoscopy did not show any dislodgement of the leads.Reprogramming was attempted and it looked like the issue was resolved.The cause of the impedance issues was not determined.No further actions/interventions were taken or planned.
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Manufacturer Narrative
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D2, d4: corrected d2 and d4.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.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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Manufacturer Narrative
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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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Search Alerts/Recalls
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