MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Retraction Problem (1536)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/24/2023 |
Event Type
malfunction
|
Event Description
|
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receive ing unknown baclofen (3120 mcg at dose was put at 200mcg/day (simple continuous)) via an implantable pump for unknown indications for use.It was reported that the catheter was placed with no issues and no hard curves within the catheter.When the healthcare provider (hcp) tried to remove the inner stylet it would not come out.There was no tension or holding the catheter tightly because it was asked to make sure.After many attempts the hcp took the catheter out of the intrathecal space and tried to remove the stylet on the back table.They pulled so hard trying the plastic hub at the top came off.At that point, they opened and placed another catheter where the stylet was removed with no problem.The issue was reported to be resolved.The patient's weight and medical history were asked but would not be made available.The patient's status at the time of this report was alive - no injury.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2023, explanted: (b)(6) 2023.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 12-dec-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.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.
|
|
Manufacturer Narrative
|
H3.Analysis identified an anomaly to the catheter/guide wire.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.
|
|
Search Alerts/Recalls
|
|
|