|
Model Number UNKNOWN SYMBOTEX MESH |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
|
Event Date 06/26/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, the patient had surgery to correct an incisional hernia that was the result of a davinci robotic gallbladder removal surgery in 2016.The patient was informed that a hernia mesh would be used to repair the hernia and this was the only option that was given.The doctor used mesh and the hernia was repaired on 2018.From that time, the patient had recurrent stomach pain and in 2020 suffered a serious stomach episode at home which included severe pain with nausea and vomiting and diarrhea that lasted throughout the entire night but the patient treated at home.In 2020, the patient again had the same type of episode but on this occasion, went to the emergency room and was hospitalized for night and treated for a small bowel obstruction with a naso gastric tube and admission into the hospital for treatment.The patient had surgery in 2020 and found that the small bowel was twisted 180 degrees and adhered to the mesh.The surgeon cut the bowel away from my mesh, leaving the mesh adhered to the tissue for fear of damaging it and the patient was admitted to the hospital for 1 night for what supposed to be a day surgery due to the fact that the patient got fever and uncontrollable pain and low blood pressure.The issue with the mesh has caused the patient to miss multiple days from the job and pain/suffering as well as numerous medical expenses.
|
|
Manufacturer Narrative
|
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.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
|
According to the reporter, the patient had surgery to correct an incisional hernia that was the result of a davinci robotic gallbladder removal surgery in 2016.The patient was informed that a hernia mesh would be used to repair the hernia and this was the only option that was given.The doctor used mesh and the hernia was repaired on 2018.From that time, the patient had recurrent stomach pain and in 2020 suffered a serious stomach episode at home which included severe pain with nausea and vomiting and diarrhea that lasted throughout the entire night but the patient treated at home.In 2020, the patient again had the same type of episode but on this occasion, went to the emergency room and was hospitalized for night and treated for a small bowel obstruction with a naso gastric tube and admission into the hospital for treatment.The patient had surgery in 2020 and found that the small bowel was twisted 180 degrees and adhered to the mesh.The surgeon cut the bowel away from my mesh, leaving the mesh adhered to the tissue for fear of damaging it and the patient was admitted to the hospital for 1 night for what supposed to be a day surgery due to the fact that the patient got fever and uncontrollable pain and low blood pressure.The issue with the mesh has caused the patient to miss multiple days from the job and pain/suffering as well as numerous medical expenses.
|
|
Manufacturer Narrative
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The evaluation found no potentially contributing factors.It was reported that the patient had experienced a medical complication as a result of device usage, significant surgical intervention was required due to the product failure, and significant tissue loss occurred as a result of the product failure the reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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
|
|
|