MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Tachycardia (2095); Insufficient Information (4580)
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Event Date 12/05/2022 |
Event Type
malfunction
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Event Description
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It was reported there was a volume discrepancy at the first refill following the pump implant.The patient was in for a refill on (b)(6) 2022 and they were expecting 14 ml however they got back 9 ml.They proceeded to fill the pump with 20 ml, waited 20 minutes for observation and sent the patient home.It was reported when the patient got home she "felt kind of funny" and her heart was racing so she went back to the office.The hcp accessed the pump again and removed 16.5 ml when there should have been between 19-20 ml in the pump.It was reported the patient had similar symptoms immediately after the pump implant but the hcp thought it might be an "after effect of sedation" at the time.The hcp removed the drug and filled the pump with saline.The issue was not resolved at the time of this report.
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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 received reported that today they checked the catheter for patency and refilled the pump under fluoro to verify functionality of pump components.No breaks or leaks observed with catheter and billows appear to expand appropriately.No volume discrepancies.No cause for the volume discrepancies have been identified.The actions and interventions taken to resolve the volume discrepancy was refill under fluoro and continued observation and monitoring of patient and volumes at future refills.The day of the report no volume discrepancies were observed.The actions and interventions taken to resolve the heart racing and "felt kind of funny" symptoms was continued observation of the patient.The symptoms seem to have resolved and a dose decrease was made the day of the report as well.
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Search Alerts/Recalls
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