Model Number 97714 |
Device Problems
Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Insufficient Information (3190)
|
Patient Problems
Muscle Spasm(s) (1966); Burning Sensation (2146); Twitching (2172); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521)
|
Event Date 04/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a health care professional regarding a patient who is implanted with a neurostimulator.It was reported that the patient says that the implant is misfiring.The patient is feeling shocking and burning sensation in the hand, and the patient¿s head and neck is twitching.The patient is also having bilateral spasms in the lower extremities (legs).The patient programmer was displaying a recharge stimulator message, and the same message was seen on the recharger.The implantable neurostimulator was discharged.The health care professional did a physician mode recharge for about 20 seconds to give the system a hard reset; however, the patient¿s reaction is still the same.It was reviewed that the stimulation was likely not the cause of the patient¿s current symptoms.There were no further complications reported.
|
|
Event Description
|
Caller is with the orthopedic office that prescribed the mri.Reviewed w/ caller the recommendation is for the managing hcp to complete the mri eligibility form when patient's ins is no working working due to being overdischarged.Provided caller with managing hcp information in drs along w/ phone number.Also discussed patient could alternatively get a new pain managing hcp and get her ins restarted again.
|
|
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.It was reported the issue of the vibration and the feeling of an electric shock was first noticed on and off since (b)(6) 2020.The patient's stimulation was changed on (b)(6) 2020 and the continuous shocking and pain did not change.The cause of the issue was not determined.It was mentioned the issue was off and on daily and was painful.No further information was received.
|
|
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
|
It was reported that the healthcare provider (hcp) wants them to have an mri due to their arm going numb and says they cant get into mri safe mode due to the ins being overdischarged.She says her arm started going numb "back in august" and says the hcp "thought it was my carpal tunnel and they want to see if i have a pinched nerve, and when i went to get the mri they told me i couldn't have it because my stimulator is in sleep mode".Pt did say the hcp does not think this arm numbness is related to device "they think its just a pinched nerve".They also clarified that back in june the reps were never able to get ins out of overdischarged state and it appears to not be able to function anymore.
|
|
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
|