MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Meningitis (2389); Insufficient Information (4580)
|
Event Date 04/10/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Continuation of d10: product id 8780 serial# (b)(4) 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)(4), ubd: 03-may-2023, 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.
|
|
Event Description
|
Information was received from a healthcare provider (hcp) regarding a patient receiving morphine (unknown dose and concentration) via implanted infusion pump indicated for spinal pain.It was reported the patient arrived at the er yesterday with a possible infection in csf.The hcp stated the patient had a bunch of symptoms and they were unsure of the source of infection.The hcp was wondering if there was a way they could withdraw csf from the pump system since they were unable to do a lumbar puncture on this patient.Additional information received from an hcp reported that the patient may have meningitis that may have been tracked from his pump system.The hcp stated the patient was having a mri of the head and was in the icu very sick.No further information was provided.
|
|
Manufacturer Narrative
|
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.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.
|
|
Event Description
|
Additional information was received from a healthcare provider (hcp) and the patient's husband (con) who reported the patient remained in the icu and was being treated for meningitis, but they were unable to confirm whether or not the patient actually had meningitis.The patient was intubated, but had since been extubated.The patient had mrsa.The hcp indicated they had no further information as the husband was no longer answering their phone.Additional information was received from a healthcare provider (hcp) and stated that meningitis was no longer a suspicion and that the patient's symptoms were not thought to be related to the device or therapy.The hcp indicated that they were not able to do a lumber puncture due to the intrathecal catheter placement.
|
|
Search Alerts/Recalls
|
|
|