B3.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.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.
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient (pt) they had a new device put in 3 months ago and as of 1 month ago, they are experiencing terrible pain in the area of the ins and it's going down.Pt states they can't sit down or stand up too much and if they push a little bit it feels like electricity.Pt states they ended up going to the hospital due to high blood pressure.Pt states they went and saw their doctor today and they ended up turning the stimulation off.Pt states so far, they still have pain.Pt states the doctor has scheduled another follow up appointment on may 11th at 9:10.The caller was redirected to pt services will notify the rep of the situation as well to see if they want to discuss with the doctor and attend the appointment.Pt states if the pain doesn't stop after turning stimulator off, they may need to look further at the device and possibly remove it.
|