MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)
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Patient Problems
Shaking/Tremors (2515); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/18/2023 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient receiving compounded baclofen (550mcg/ml concentration at 235mcg/day dose) and dilaudid (hydromorphone) (1mg/ml concentration at 0.42mg/day dose) via an implantable pump.The indications for use were unknown.It was reported that patient was experiencing withdrawal symptoms.The pump was replaced at 18:00 on (b)(6) 2023, and by 07:00 on (b)(6) 2023, the patient was shaking and exhibiting symptoms of withdrawal.The patient was given a bolus with no change in symptoms.The patient returned to the operating room (or) to check the catheter, but there was no signs of it being kinked.The connection piece was removed and a new pump segment was added.The physician changed the medication to baclofen only.The patient's weight and medical history were asked but unknown.The patient's status was alive with no injury.It was noted that the hcp had no further information at the time of the report.The resolution of the event was unknown.
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Manufacturer Narrative
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Continuation of d10: product id 8709sc lot# n230631010, implanted: on (b)(6) 2009, product type catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8709sc, lot #: n230631010, ubd: 2011-10-27, udi#: (b)(4).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 was received from a healthcare provider (hcp) via a company representative (rep) indicated the cause of the withdrawal post-operative was unknown.The catheter issue was not confirmed during the revision and it would be sent for evaluation.
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Manufacturer Narrative
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H6.Correction: device code: a1407 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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Manufacturer Narrative
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Analysis of the catheter revealed sc connector-coring/tears in seal; meets leak criteria.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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