MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of consciousness (2418); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/27/2021 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving morphine (7 mg/ml at 2,7980 mg/day) and bupivacaine (4.9 mg/ml at 1,9586 mg/day) via an implantable pump.It was reported that a usual pump refill procedure was carried out, and 48 hours later the patient was admitted to the intensive care unit with symptoms of morphine overdose.As of (b)(6) 2021, the patient was currently hospitalized, unconscious, and intubated.It was being considered that if the dose was 2,7980 mg/day, then it means 0,4 ml/day.It was further noted that if the refill took place on (b)(6) 2021 and they had emptied the reservoir on (b)(6) 2021 (2 and a half day more and less), then they took around 38,5 to 39 ml out.It was therefore being considered that at this time, the ml infused was 1 ml and the infusion could be consider normal by the doctor.On (b)(6) 2021, the patient continued with the same symptoms without drugs in the pump for 3 days.It was noted that there were no known factors that may have led or contributed to the issue.The physicians were talking about what to do, but for the moment the company representative had not been informed.It was unknown if the pump was to be replaced.No surgical intervention occurred, and no surgical intervention was planned.The pump remains implanted and out of service.The patient was with injury regarding their status as of (b)(6) 2021.It was further indicated that at the moment they were in touch with the hospital to see what they want to do, because they were performing another diagnostic exam as the patient had other problems too.Regarding the other problems, it was clarified that the patient had other health problems as epoc and the physician was doing a test to rule out any relationship between the symptoms and his other problems.It was indicated that the exam/test was not related to the pump.The company representative later further reported on (b)(6) 2021 that yesterday they were in the hospital to interrogate the pump and check the pump activity logs.There was not any report after the refill day (b)(6) 2021.The logs provided showed no indication of alarms, only programming steps from (b)(6) 2021 through (b)(6) 2021.As of (b)(6) 2021, the physicians didn¿t know what the cause of the patient¿s other health problems were.Regarding the cause of the patient having been admitted with overdose symptoms and was unconscious, the physicians believed thought the overdose was the cause, but they didn¿t know what was the cause of it.No further actions were planned at the moment (as of (b)(6) 2021).The patient was better and was going to be extubated.The pump was working without drugs inside, and they don´t know yet what to do.If they decide to explant the pump they were to contact the company representative to give the company representative the pump for a full check.The patient's medical history, age, and weight at the time of the event was unknown.
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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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Additional information was received form a foreign healthcare provider via a company representative.Regarding causal or contributing factors including the device, therapy, or a device procedure with respect to the patient¿s passing, the physician thought the pump was not a problem.Regarding the actual volume withdrawn from the pump and the volume expected, the physician indicated that the volume expected had coincided with the volume withdrawn.No additional pump volume checks had been performed.
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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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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 via a company representative.It was indicated that a relative had informed the company representative at the hospital, that some time ago the patient¿s previous pump was refilled subcutaneously outside the reservoir causing an overdose.Refer also to mfr report # 2182207-2022-00250 regarding prior event / prior pump.It was further noted that the patient had the same symptoms after the pump was last refilled on (b)(6) 2021 in spain.On (b)(6) 2021 to (b)(6) 2021 the patient was not responding and was brought to the hospital.The patient could not talk with symptoms that the patient¿s relatives related to the previous event on the overdose experienced with the previous pump.The patient was given naloxone in case it was overdose, but the patient did not respond to this medication.It was supposed also that it could have been a stroke, so the company representative was told further tests, among these tests a ct, were going to be done.The pump had been read on (b)(6) 2021.On (b)(6) 2021 the patient seemed to be better and was about to be extubated.It was however further noted that the patient had later died in gibraltar (uk).The date of death was not specified.Regarding cause, it was reported that the pathologist indicated the death probably wasn¿t the pump, but he wanted to be sure and therefore wanted the pump analyzed.
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Manufacturer Narrative
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H6 correction: patient code e2402 and imf annex f f2303 were previously not coded in error.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 via a pathologist via a company representative.The pump had been refilled in spain on (b)(6) 2021 with 40 ml total that included 14 ml morphine (2mg/ml) and 26 ml 0.75% bupivacaine.The programmed rate was 2.79 mg morphine per day (0.13ml) and 1.95mg/day of bupivacaine (0.26ml) giving a total of 0.4ml/day.The patient was admitted to a hospital on (b)(6) 2021 with a low gcs (glasgow coma scale), which was thought to be secondary to an opiate overdose as a result of the intrathecal catheter and pump device.On admission to the intensive care unit (icu), 38ml were aspirated from the pump raising concern she had received 4-5 times the daily dosage.The pump was recovered from the body at autopsy.Interrogation of the device and analysis to evaluate whether there had been a malfunction with the device was requested.
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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.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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