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 Problem
Discomfort (2330)
|
Event Date 11/13/2015 |
Event Type
Injury
|
Event Description
|
Information was received from a patient who was receiving fentanyl and bupivacaine via an implantable pump for unknown indications for use.It was reported that with their previous pump implant, 'from the get go, it was a pain in the butt.I only had the option of what side of my stomach i wanted it on, and since i had scar tissue on one side, i went with the other side.It was placed where your pants go, so i either had to wear my pants low or at my chest.I also held my pump when i bent over and it was uncomfortable in the spot they put it.So, i had the healthcare provider move it to my back left area over my left si (sacroiliac joint) so it's behind me now.'.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|