MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of consciousness (2418); Decreased Respiratory Rate (2485)
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Event Date 02/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving compounded baclofen, hydromorphone, and clonidine via an implantable pump for unknown indications for use.It was reported that the patient's pump and catheter were replaced on (b)(6) 2022 secondary to normal battery depletion and an occluded catheter. later that evening, the patient became unresponsive and experienced respiratory depression.Two doses of narcan were administered and the therapy was suspended via magnet. on (b)(6) 2022, the patient's symptoms improved, but they complained of severe pain, as the therapy was suspended.The magnet was removed to resume therapy and the it rate was decreased by more than 50%.It was indicated the event was related to the device or therapy and related to the hydromorphone.The event resolved without sequelae on (b)(6) 2022.
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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 received from a healthcare professional (hcp) via a clinical study updated the event date to (b)(6) 2022.
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Event Description
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Additional information was received from healthcare provider via a clinical study indicated that the patient experienced a second episode of respiratory depression after the therapy was resumed the day prior.Overnight a magnet was placed over the pump and removed at about 2:00am.The patient then became sedated and the therapy was replaced on the pump again to suspend therapy.The magnet was removed around 10:00am and the it rate was decreased 50%.
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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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