Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastroparesis.It was reported that the patient's ins had turned off sometime earlier last week, so they went to their managing health care provider (hcp) office on tuesday ((b)(6) 2022) where they checked the implanted device.The patient stated the managing health care provider (hcp) determined that the impedance level was ok, they could detect no issues, and the hcp turned it back on.The patient stated they hadn't gone through any type of electromagnetic interference (emi) that they could think of and that they only had a microwave in their house that they hadn't used.The patient stated the physicians couldn't determine what happened and that they had called to report this event, however now the patient was concerned it had turned off again last night because they weren't feeling anything now.The patient stated they would usually feel it when it was on and that now they weren't.The patient was hoping it wasn't true and that they were just imagining things but they were going to call their hcp office to discuss the issue.The patient did not know of a representative working on their case but patient services also sent an e-mail to the field to alert them of the situation.The patient stated their hcp was 2 hours away from them.
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Date of event: date is estimated; month and year are 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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