MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-723RNAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hyperglycemia (1905); Myocardial Infarction (1969); Pneumonia (2011); Suicidal Ideation (4429)
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Event Date 01/18/2022 |
Event Type
Death
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Manufacturer Narrative
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(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.
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Event Description
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It was reported via phone call that the customer passed away at home on (b)(6) 2020.The customer was hospitalized on unknown date.The customer committed suicide.The customer¿s blood glucose was 900 mg/dl at the time of death.Customer got pneumonia, heart attack and stroke all within a week.It was unknown if the caller will return the insulin pump for analysis.
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Manufacturer Narrative
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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.This case was created in error and is a duplicate to manufacturing report number: 2032227-2022-105773.
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Event Description
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Customer's wife reported that customer was working outside and overdid himself.Customer got pneumonia, had a heart attack, and a stroke all within a week.Customer had high blood glucose of 900mg/dl during all of these occurrences and was hospitalized.After they returned home from the hospital, she found the customer sitting on the back porch late at night in the cold.When she asked the customer why they were outside, she saw that the customer had killed himself.Incident date is january 18, 2022 per sap for pump (same as notified date since no specific date of high bg was given).Customer passed on (b)(6) 2020.It is unknown if the pump was used at the high blood glucose event.It is unknown if sensor was used.
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Manufacturer Narrative
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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.Information has been corrected which was not correct in the initial report.The information has been provided in section b5 with this report.
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