MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Excess Flow or Over-Infusion (1311); Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
Event Type
Injury
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Event Description
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Information was received from a manufacturer representative regarding a patient who was receiving unknown baclofen (unk mcg/ml at unk mcg/day) via an implantable pump for unknown indications for use.It was reported that the company representative (rep) stated that the patient was diagnosed with a catheter issue last summer and today the patient had a catheter revision.They aspirated the drug from the pump today and pulled 40 ml out of the pump and should have been much less.Discussed concerns with pump and catheter patency.Discussed with healthcare provider (hcp) to replace the pump.
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Manufacturer Narrative
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Continuation of d10: product id: 8780, serial# (b)(6), implanted: (b)(6) 2022, product type: catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 26-sep-2024, 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) and company representative (rep) reporting that the patient's weight at the time of the event was unknown.It was reported that the cause of the catheter issue was that the patient's pump was flipping.It was reported that the surgeon cut the catheter in the pocket and immediately started to see flow.A new 8784 was attached and the catheter aspirated successfully via the catheter access port (cap).It was reported that the issue was resolved and the old portion of the catheter was discarded.
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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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