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
Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/04/2023 |
Event Type
Injury
|
Event Description
|
Information was received from the consumer (con) via the company representative regarding a patient receiving morphine (dosage/concentration were unknown) bupivacaine (dosage/concentration were unknown) via an implanted pump.The indication for use was non-malignant pain.The company representative reported the patient had a pump replacement on (b)(6) 2023 and was in the er last night with symptoms including seizures.The rep stated they are not sure whether symptoms are related to the pump but wanted to report it anyway.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id: 8637-40; lot#: serial#: (b)(6); implanted: on (b)(6) 2023, product type: pump.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.
|
|
Event Description
|
Additional information was received from the rep.It was reported that the patient weight was unknown due to hipaa.The seizures, other symptoms, and er visit were deemed not related to the device or therapy.No further actions were taken to resolve the seizures, other symptoms, and emergency room visit.The issue was resolved.
|
|
Manufacturer Narrative
|
Review of this mdr, as well as the 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 no longer meets the reporting requirements stipulated in 21 cfr 803.H6 codes have been updated to reflect the new information provided.Additionally, upon review, the device was incorrect in the initial report, and was corrected in section d of this report.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
|
|
|