Model Number 37800 |
Device Problem
Electromagnetic Compatibility Problem (2927)
|
Patient Problems
Vomiting (2144); Insufficient Information (4580)
|
Event Type
Injury
|
Event Description
|
Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for gastroparesis.It was reported that their mom has a gastric stimulation for gastroparesis.They believe it was somehow turned off during surgery.They need a manufacturer representative to scan the device and turn it back on as soon as possible.The patient is very sick.
|
|
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.
|
|
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.
|
|
Event Description
|
Additional information was received from the patient representative.They reported that nothing has been done to fix this issue yet.The patient¿s hcp is in indianapolis, which is far away from where the patient is.The patient has been in and out of the hospital and is currently in the hospital.The patient suspects that the cause of the hospitalization is because the gastric stimulator keeps getting turned off in surgery.The patient is extremely sick and can¿t keep anything down.The patient ate a few days ago, and it all came back up.They are trying to find a manufacturer representative (rep) that can help with this situation but are really struggling and getting very frustrated.They reiterated that the hcp is so far away that it¿s hard to get the patient there.
|
|
Search Alerts/Recalls
|
|