MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
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 05/12/2022 |
Event Type
Injury
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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 dilaudid 50mg/ml at 1 4.24mg/day, marcaine 7.5mg/ml at 2.13mg/day and clonidine 150mcg/ml at 42.72mcg/day via an implantable pump.It was reported that the pump was inadvertently stalling.During refills, the staff noticed that the pump had more in it than the tablet was indicating, meaning the pump was stopping therapy between refills.The staff observed extra drug in pump over a couple refill appointments.That¿s how they determined the pump was stalling or stopped pumping drug.The environmental, external or patient factors that may have led or contributed to the issue as well as the diagnostics and troubleshooting performed was noted as ¿n/a¿.The pump was replaced with a new pump.The issue was 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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