MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problems
Fluid/Blood Leak (1250); Retraction Problem (1536)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/10/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id 8780 implanted: (b)(6) 2022 product type catheter.Other relevant device(s) are: 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 healthcare professional (hcp) via a company representative (rep) regarding a patient receiving lioresal (unknown concentration and dose) via an implantable pump.It was reported after the surgeon placed the ascenda catheter into the intrathecal space of the spine, verified cerebrospinal fluid, and removed the needle and stylet it was noticed the stylet was very coiled and twisted.The stylet was pulled straight out of the catheter with no angle or abnormal tension.The catheter was then tunneled to the pump pocket, and afterwards a leak in the spinal pocket where the catheter was originally placed was noted.It was suspected that the coiled stylet punctured the catheter spinal segment and had caused this.The catheter was then completely removed after the leak was noticed and a new 8780 catheter was placed.It was reported the removed catheter would be returned.Patient weight and medical history was asked but remain unknown.At the time of this report the issue had been resolved and the patients status was alive - no injury.
|
|
Manufacturer Narrative
|
Analysis of the catheter identified an anomaly to the catheter/guide wire.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
|
|
|