Model Number 37800 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Nerve Damage (1979); Swelling/ Edema (4577)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Outcomes attributed to adverse event: nerve damage date of event: event date is estimated.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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient had called to inquire about mri compatibility for their enterra stimulator.Reviewed this information and the patient reported that they started swelling up real bad again last year (patient confirmed in 2021) and so they went to the physician and they were told the stimulator quit working.The patient stated the physician told them that sometimes the device would burn the nerves and it would quit working.Asked if the stimulator had quit working because the battery had died and the patient said no, that they checked the battery, but it wasn't that, but it quit working, so they cut the bottom of the patient's stomach out instead and "that stopped all my colon up." the stomach surgery had occurred last summer and that it made a world of difference for them and that they wished they'd have done that first.The patient's implanting doctor is 3 hours away so a physician listing was mailed to them.
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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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Event Description
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Additional information was received from the patient.They reported that caller stated patient's device is not working and they need to have it removed for mri purposes (lesions on liver) but patient lost physician listings.
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Search Alerts/Recalls
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