MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/27/2022 |
Event Type
Injury
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Event Description
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Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient with an implantable pump.On (b)(6) 2022, it was reported that the patient reportedly experienced a critical and non-critical alarm during what they believed was a flex bolus step.Each alarm reportedly only sounded 1 time.Patient then experienced withdrawal symptoms and headed to the emergency room.When pump was interrogated 3 to 4 hours after alarms, there was nothing in the logs to identify the alerts.The programming tablet was turned off and then on but still no alarms showed in the logs.The pump was interrogated several times with the same result.No environmental/external/patient factors that might have caused or contributed to this issue were reported.It was noted that the patient was on flex dosing with a dose every 3 hours.The following dose interval was administered by pump and seemed to be working properly.The patient confirmed that they could feel the following 3 hour dose.The hcp programmed a single additional bolus an supplemented with oral medication.It was unknown if the issue was resolved at the time of the report.No surgical intervention occurred or was planned.The patient's status was listed as "alive - no injury".Additional information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) on 2022-jan-03.It was confirmed that the pump logs were checked and not just the status of the pump.No alarms were seen in the logs and no "silence" feature was used.No programming changes oc curred prior to the patient seeing the hcp.It was noted that the patient accurately described the alarms that they heard and confirmed that pump alarms were what they heard when the alarms were demonstrated for them.The patient was also unaware of any different circumstances that might have caused electromagnetic interference with the pump; the patient was at home in their normal environment.No falls or trauma were noted.The volume aspirated during refills varied somewhat, but nothing extraordinary was noted.The variability was consistent with the entire patient group.The hcp did not feel that the patient's withdrawal symptoms were not a general response to the missing of a bolus dose or interruption of the pump, given how quickly the symptoms began.It was confirmed that the patient had not experienced any further alarms.
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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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