MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Anxiety (2328); Diaphoresis (2452); Insufficient Information (4580)
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Event Date 02/17/2024 |
Event Type
Injury
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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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Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal dilaudid and baclofen (unknown c oncentrations and doses) via an implanted pump for intractable spasticity.It was reported that the patient was concerned their pump was malfunctioning and felt like the pump was giving too much medication.It was reported that the patient was awake and alert.It was reported that the patient was having secretion production and anxiety and stated they had these symptoms in the past due to a prior pump malfunction.The patient also reported having a lot of gastrointestinal (gi) symptoms and gi motility issues.The patient did not have any reprogramming recently or a refill or any recent pump adjustments.It was reported that someone was set up to check the pump.
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Manufacturer Narrative
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H1 correction: type of reportable event corrected to serious injury.H6 correction: imf codes updated.Code e2310 is not applicable to this event.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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Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal dilaudid and baclofen (unknown c oncentrations and doses) via an implanted pump for intractable spasticity.It was reported that the patient was concerned their pump was malfunctioning and felt like the pump was giving too much medication.It was reported that the patient was awake and alert.It was reported that the patient was currently on a vent.It was reported that the patient was having secretion production and anxiety and stated they had these symptoms in the past due to a prior pump malfunction.The patientalso reported having a lot of gastrointestinal (gi) symptoms and gi motility issues.The patient did not have any reprogramming recently or a refill or any recent pump adjustments.It was reported that someone was set up to check the pump.
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Search Alerts/Recalls
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