MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Disconnection (1171); Protective Measures Problem (3015); Insufficient Information (3190)
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Patient Problems
Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a healthcare provider regarding an implanted pump system for intractable spasticity and cerebral palsy.The pump was used to deliver unknown baclofen.Dose and concentration information was unknown.It was reported that the patient's managing physician was unable to see the catheter on x-ray and computed tomography (ct).The physician was inquiring if this was normal and how to locate the catheter.Dye study information was reviewed.It was noted that the patient was on a low dose of baclofen.The physician wasn't sure if the medication was going subcutaneously, as she could not see the catheter placement.No patient symptoms or complications were reported.On 2023-mar-07, additional information was received from the healthcare professional (hcp).The hcp inquired about the lowest programable flow rate.Information was reviewed.The hcp stated the surgeon suspects the catheter was not functioning as expected.The hcp stated the surgeon could not see the catheter pin under fluoro and stated they were not confident it was there so they did not want to do a dye study.
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Manufacturer Narrative
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Continuation of concomitant medical product(s): product id 8781, serial# (b)(4), implanted: on (b)(6) 2016, explanted: na, product type catheter.Device information references the main component of the system.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 14-oct-2017, 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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Manufacturer Narrative
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H6: corrected information: device code a26 and patient code e2403 no longer applicable.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 received reported that the pump was being permanently shutdown today due to the system "not working." per the healthcare provider about two months ago, the patient had an x-ray done and it showed the catheter was disconnected from the pump.When the healthcare provider was asked about therapeutic relief they stated, "well he has always had some baseline spasticity." the healthcare provider was provided code 3541.
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Search Alerts/Recalls
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