MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2022 |
Event Type
Injury
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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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Information was received from a healthcare provider via a company representative regarding a patient receiving fentanyl 2000mcg/ml at minimum rate, clonidine 250mcg/ml at minimum rate and marcaine 0.9mg/ml at minimum rate via an implantable pump.It was reported that the physician saw the patient for a refill on (b)(6) 2022 after interrogating the pump the physician saw pump motor stall notification and also that the pump had been stalled for approximately 550 hours.The physician also had a significant reservoir discrepancy of approximately 11ml's.The environmental, external or patient factors that may have led or contributed to the issue was the patient stated they had an mri approximately 1 month ago but did not have the pump interrogated after the scan.The diagnostics and troubleshooting performed was the physician re-interrogated the pump to see if motor stall resolved in the logs.He stated that the motor stall did not recover in the logs after pump interrogation.The actions and interventions taken to resolve the issue was the pump was programmed to minimum rate and the patient was referred for pump replacement.Surgical intervention did not occur but was planned though not scheduled.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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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 they expected 5.5 ml and aspirated 16 ml.
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Search Alerts/Recalls
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