MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
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 09/01/2022 |
Event Type
malfunction
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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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Event Description
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Information was received from a company representative regarding a patient receiving fentanyl (500 mcg/ml, 78 mcg/day) via intrathecal pain pump indicated for non-malignant pain.It was reported the patient's pump was empty and the rep wanted to know what they needed to do to silence the alarm.The pump was not going to be filled at the moment.No further information or symptoms were reported.Additional information was received from a company representative.It was reported that the patient had moved to north carolina and did not find a doctor ahead of time.The patient had the pump go empty as a result and so the pump was filled with saline on (b)(6) 2022 and was set to min rate.The rep noted on (b)(6) 2022, they planned to fill the pump with the same drug (500 mcg/ml fentanyl) that was in when the pump went empty.No symptoms were reported.Additional information was received from a company representative (rep).Patient information, pump serial number, initial reporter, and patient weight were provided.The patient reached out to her doctor in louisiana who contacted a local rep who was able to get the patient scheduled with a local provider to refill the pump.The pump was refilled and the issue was resolved.
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Search Alerts/Recalls
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