MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Pumping Stopped (1503)
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Patient Problems
Pain (1994); Sleep Dysfunction (2517)
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Event Date 02/07/2021 |
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 consumer (con) regarding a patient who was receiving fentanyl (400 mcg/ml at 450 mcg/day) via implantable pump for non-malignant pain.It was reported that the patient's pump started alarming about once every half hour and now is every 10-15 min.Patient services heard alarm in the background of call and confirmed the critical alarm is going off.Their pain has increased and he has not been able to sleep well.They are not due for a refill until (b)(6) 2021.Patient services reviewed meaning of critical alarm and redirected to healthcare provider (hcp) to further address and to seek medical attention as needed.The patient also mentioned his catheter had "stopped" in the past before when they switched over to fentanyl and did not provide additional information.Additional information was received from a healthcare provider (hcp) on (b)(6) 2021 regarding the patient.The hcp wanted help pulling the logs.They pulled logs and it was seen the pump stalled on (b)(6) 2021 and has been intermittently stalling since.There were no external factors and no electromagnetic interference (emi) or magnets.They are planning on replacing the pump as soon as possible and sending it back for analysis.Troubleshooting was unable to be performed.
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Event Description
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Additional information was received from the device manufacturer representative indicated that the pump was being replaced today and would be sent back for analysis.
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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.
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Manufacturer Narrative
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Analysis of the pump revealed a motor gear train anomaly regarding corrosion and/or wear and/or lubrication; stall was due to the shaft bearing.Analysis noted residue and wearing on the upper shaft of gear number two.As per the pump¿s logs, fentanyl with concentration 3,000.0 mcg/ml was being administered at a dose rate of 550.0 mcg/day as of (b)(6) 2019.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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