MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
Cognitive Changes (2551)
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Event Date 12/31/2021 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) and a company representative regarding a patient receiving baclofen (2000 mcg/ml) via an implanted pump.The patient thought the dose was 1020 mcg/day.The indication for pump use was intractable spasticity.The hcp reported that the patient was in the hospital with an altered mental status.The patient was taking oral baclofen but had not had a significant improvement in symptoms, so due to this, the hcp wanted the pump interrogated to make sure it was infusing properly.Additional information was received the same day from a company representative who reported that he went to the er (emergency room) to interrogate the pump and it was alarming.The pump was saying, ¿safe mode - pump in minimum rate mode¿.In safe mode/minimum rate mode the pump was delivering 12 mcg/day.No other alarms were noted in the logs.The patient was at home when the safe mode triggered.
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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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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 the cause for the pump going into safe mode was not determined.The actions and interventions taken to resolve the issue was they reset the pump to simple continuous on 02-jan, 1020mcg/day.The device remains implanted with no plans to do more.
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Search Alerts/Recalls
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