(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.
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Medtronic legal received information regarding that insulin pump's retainer ring was missing or broken from the attorney of the family.Customer reported hyperglycemia and diabetic keto acidosis and coma condition.The information received on february 17, 2022.Attorney reporter alleges that use of medtronic insulin pump caused personal injury to the customer.The attorney of the family reported that the pump had damaged, missing, or broken retainer ring that resulted in hospitalization for high blood glucose, diabetic ketoacidosis, possible cardiac event, and coma (pending records) per sap for pump.This case is for the (b)(6) 2017 incident per sap for pump.Please see (b)(4) for the (b)(6) 2018 incident and (b)(4) for the (b)(6) 2018 incident.Dates are pending records.No harm requiring medical intervention was reported.The customer will discontinue to use the device.
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