Model Number 37800 |
Device Problems
Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927); Data Problem (3196)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: date is estimated; year is valid.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 gastric stimulation.The reason for call was the patient reported they had their ins battery replaced on (b)(6) 2023 (due to normal battery depletion).The patient reported that usually a manufacturer representative (rep) would be there to turn the ins on however they weren't there and the patient went home wondering if the implant was even on.The patient reported they were then miserable for 4 weeks from their symptoms and they didn't know why until they went to their 4 week post-op follow up and they were told that the ins had been off.The patient stated the surgeon told the patient that they turned the ins on before the patient left the hospital and suggested a magnet or microwave could turn the ins off.The patient stated they didn't know how that would be possible as they'd been on bedrest since the implant.The patient indicated they were thinking the ins just hadn't been turned on before they left the hospital but wanted to call to confirm.The patient stated they'd call back if they had any further questions or concerns but as of now the therapy was on and the patient's reason for call was addressed.No further action was taken by patient services.(b)(6) 2023 lfc (hcp): additional information was received from a healthcare professional (hcp).The hcp reported that there was no record of the ins being turned off.The cause of it turning off by itself is unknown.They turned it back on, and the issue has been resolved.
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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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