MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
|
Event Type
Injury
|
Manufacturer Narrative
|
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 patient representative and a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system.The pump was used to deliver unknown baclofen.Dose and concentration information was unknown.It was reported that, on (b)(6) 2022, the patient was bleeding around their gastrostomy tube about a month after surgery.The patient was kept in the hospital for one week and they "couldn't find anything".The patient was showing signs of infection and bleeding.The patient was sent home on (b)(6) 2022and was back on (b)(6) 2022.The area around the patient's pump was tested the next morning and was infected.The pump was explanted on (b)(6) 2022 due to the infection.The device was not replaced but would be replaced in the future.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the event.At the time of this report, the issue was resolved and the patient status was "alive-no injury".The patient's weight and medical history were asked but were unknown.The date that the event occurred was asked but was unknown.
|
|
Search Alerts/Recalls
|
|
|