MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954)
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Patient Problems
Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2021 |
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 a friend/family member regarding a patient who was receiving dilaudid (hydromorphone) (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that the patient was in the hospital because their pump failed and had to be replaced.It was determined on (b)(6) 2022 that the pump failed and reported volume discrepancy; however, they are not sure where all the medication was leaking from.It was noted that a medtronic representative took the pump and was sending it back for analysis.
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Manufacturer Narrative
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H3: analysis of pump s/n (b)(6) identified no anomalies.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) who reported that on (b)(6) 2021 the pump was refilled with 21 ml, and 30 minutes later the patient had an altered mental status (ams).12 ml was aspirated from the pump pocket and 5 ml was in the pump.On (b)(6) 2022, the pump was refilled with 21 ml and the patient had ams once he arrived home.The pump was aspirated and found to have 18 ml.With regards to any external, environmental, or patient factors that may have caused or contributed to the event, it was noted that both refills were unremarkable technically.With regards to if the issue was resolved, the hcp noted that it was unclear yet if replacement of the pump fixed the issue.
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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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