Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Electric Shock (2554)
|
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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that they were having trouble with the ins.Patient reported shocking when laying down and their right leg was hurting pretty bad but their lower back was way worse.Patient reported it hurts to move.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 977a260 lot# serial# (b)(6), implanted: (b)(6) 2018, explanted: product type lead product id 977a260 lot# serial# (b)(6), implanted: (b)(6) 2018, explanted: product type lead.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
|
The patient reported that starting a few months ago pt no longer thought their stimulator was working anymore and the pt thought it was because of their back.Then pt was told in september the it traveled down; pt said they just got a spinal fusion and it showed one of the leads had traveled down an inch in their back.Pt was trying to get a representative to look at it or to get it reprogrammed.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2018 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2018 product type lead.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 on december 10, 2021.The manufacturer representative (rep) reported that the patient was having decreasing pain relief from the stimulator.The patient could not identify anything that could have caused the leads to migrate down.It was noted the leads migrated down to a position that no longer allowed for reprogramming, so the patient has turned the implanted neurostimulator (ins) off and has been scheduled to discuss lead revision with their doctor.Issue was not yet resolved.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2018 explanted: product type lead 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 from the rep stated that a paddle lead revision is planned but has not been scheduled yet.Ins will not be replaced.Patient's weight at the time of the event was 190 lbs.The current percutaneous leads should be able to be returned.
|
|
Search Alerts/Recalls
|