MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Urinary Retention (2119); Dysphasia (2195); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/03/2022 |
Event Type
Injury
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Event Description
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Information received from a healthcare professional (hcp) via a company representative (rep) regarding a patient receiving intrathecal medication morphine 2 mg/ml at 0.9 mg/day, clonidine 20 mcg/ml at 9.2 mcg/day, and baclofen 10 mcg/ml at 4.6 mcg/day via an implantable pump.It was reported the patient was hypotensive and admitted to the emergency department and placed on a narcan drip.The physician reported the pump was set to minimum drug rate on (b)(6) 2022, then the pump was stopped for 48 hours to see if the patient stabilized.Physician stated the patient was in critical condition.It is unknown if any environmental, external, or patient factors led to the event.Patient weight and medical history were asked but remain unknown.At the time of this report the patient status was alive - no injury, and the issue had not been resolved.
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Manufacturer Narrative
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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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Event Description
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Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the pump was permanently turned off on (b)(6) 2022.After speaking with the managing office, the patient was refilled the prior tuesday ((b)(6) 2022).Then, the patient¿s family brought her back to office on (b)(6) 2022.For slurred speech and urinary retention.The physician on duty asked her to follow up with the primary care provider to rule out a urinary tract infection (uti).The pump was now off, and patient was alert and returned to baseline.It was further reported on (b)(6) 2022- that once we turned the pump off, the patient no longer needed narcan, she returned to baseline and was alert, according to hospitalist.The patient was refilled prior to this event.A uti was not confirmed.It was unknown if the device or therapy was causal or contributory with respect to the patient¿s symptoms and need for narcan.It was also unknown if the event was related to the device, therapy, or refill procedure.It was also reported the doctor was not sure why this occurred.
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Manufacturer Narrative
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H6.Annex g code: g07001 was updated/corrected to g04105.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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