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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Information was received from a friend/family member regarding a patient who was using an implanted neurostimulator (ins) for gastroparesis.It was reported that the patient could feel a little bit of a shock sometimes from their device.The caller stated the patient was at their check up and they asked if the patient felt any shocking or tingling, and the patient stated "yeah, every once in a while." the caller stated they couldn't tell us exactly when it first happened because the patient had never fussed to them about it, but every once in a while the patient would say "put your hand here," and the caller could feel "just a little tiny jerk." the caller stated they then turned it down, but when they did, it "wasn't working either" and the patient got other side effects but they feel like they finally got it regulated to where it was really working best for the patient, to keep the patient's bowels moving and everything going, so the caller stated if the patient got a little shock, the patient thought they could put up with that versus going without.The caller stated they didn't want to turn it down, because they'd already tried it before and they were happy where the patient was at.It was confirmed with the caller that when the settings were lower, it wasn't helping the patient's symptoms, but when it was turned up, it was helping the patient's symptoms but they would get a little shock every now and then.
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