MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/05/2022 |
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 who was receiving clonidine at 547.4mcg/day via an implantable pump.On (b)(6) 2022, it was reported that the patient's pump motor stalled at 1:04 pm and restarted at 1:09 pm the same day, (b)(6) 2022.On (b)(6) 2022, the pump motor stalled again at 9:57 pm and the motor did not restart again.The patient was admitted to the emergency room for withdrawal symptoms the night of (b)(6) 2022.When the pump did not restart on (b)(6) 2022 following an unsuccessful attempt at interrogation, the hcp decided to change the pump.The pump was replaced on (b)(6) 2022.It was unknown what, if any, environmental/external/patient factors might have led or contributed to the issue. the issue was considered resolved at the time of the event.The patient's status was listed as "alive - no 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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Manufacturer Narrative
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H3: the pump was returned, and analysis found corrosion and-or wear and-or lubrication and stall due to shaft-bearing.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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