MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/25/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id 8780, serial#: (b)(4), implanted: (b)(6) 2013, product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-dec-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving morphine (2mg/ml) via an implantable pump for non-malignant pain.It was reported that the patient had two catheter leaks in their catheter after a previous surgery and the catheter was replaced.The cause of the catheter leaking was unsure.It was noted the hcp previously did a dye study on the catheter.It was noted the issue was resolved.
|
|
Event Description
|
Patient experienced increased pain.It was unknown if it was related to pump.The cause of the catheter leak was not determine.
|
|
Manufacturer Narrative
|
Continuation of d10: product id: 8780, serial# (b)(6), implanted: (b)(6) 2013, product type: catheter.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
|
|
|