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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It was reported that when the physician conducted telemetry during outpatient periodical care consultation, the implantable neurostimulator (ins) was in a factory (initialized) setting.It seems like alerts did not appear.There were no indications that ins telemetry was performed at other facilities.The implanting physician stated than an abnormal current might occur due to electromagnetic waves or something and they were investigating it.According to the patient, there were factors that may have led to the event such as cataract surgery (diathermy was used), laser surgery at the dentist, use of dental drills, ct imaging (taken 2 years ago), passing near the machine where electromagnetic waves flow during rehabilitation, using an electric bike, etc. the patient programmer (pp) was not handed over at this facility due to policy, so the power was not turned off during the operation.According to the physician, it seemed that the patient had a few symptoms with a high possibility that the symptoms occurred before the telemetry.Potential factors for programming lost were reviewed.The physician stated that everything including information on lead details had to be re -entered, which would indicate deletion of basic information, but the physician has never seen the factory setting and therefore, cannot exclude it.The patient's settings were reprogrammed on march 2nd and the problem was resolved.
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