Model Number 37800 |
Device Problems
High impedance (1291); Unstable (1667); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Nausea (1970); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2020 |
Event Type
Injury
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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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Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor therapy.It was reported that the ins had been doing well but started to flip towards the right side when they roll over on their side or when laying down.When it does flip it seems to make them very nauseated.The patient was interested in getting it fixed back down.The patient had denied any new medical history.They were in the emergency department on (b)(6) for abdominal pain and gastroparesis.A revision was schedule on (b)(6) 2020.
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Event Description
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Additional information was received from a manufacturer representative (rep).The rep reported that the patient had a pocket revision yesterday.No further complications were reported/anticipated at this time.
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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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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id 4351-35 lot# serial# (b)(6), implanted: (b)(6) 2017 explanted: 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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Event Description
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Additional information was received from a manufacturer representative (rep).The rep reported that patient was seen in the office today by dr.And the impedance was out of range.One of the leads was over 4,000.Dr.Turned that lead off and made the can positive.The hcp plans on taking the patient to surgery to exchange the battery or the lead that is causing the issue.
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Search Alerts/Recalls
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