MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problems
Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/11/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product id neu_unknown_prog, lot#, serial# unknown, implanted, explanted, product type programmer, physician.Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_prog, serial/lot#, unknown, ubd, udi#.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from the healthcare provider via a device manufacturer representative regarding a patient receiving morphine (2000-3000 mg/ml at 600 mg/day) via an implantable infusion pump.It was reported that bridge programming was performed 27hrs ago and the patient was brought back to the office today because the duration was too long.It was stated that the calculated duration was based off 200mcg/day (107.5 hrs) but the patient actually gets 600mcg/day.The caller was assisted with calculating the correct dosage.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id a810 serial# unknown product type software.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
|
|
|