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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Break (1069); Battery Problem (2885); Patient Device Interaction Problem (4001)
Patient Problems Burning Sensation (2146); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 26-oct-2021, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 26-oct-2021, udi#: (b)(4).The following products are reported in a separate regulatory report.See report #3004209178-2021-06703.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 97715, serial#: (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient has two systems implanted, cervical and thoracic.The patient stated hat her cervical implant has always caused her issues, specifically burning in her throat.She also reports having 4 grand mal seizures post nuss procedure.They believe this was caused by a new medication initiated post-procedure.The cervical was done after her seizures which shows electrodes on both leads that appear to be fractured.The rep attached an image for reference.The cervical ins was dead at the time of the report.The rep was unsure if the cervical lead issue happened before or after seizures but imaging post-seizure did show what appeared to be fractured leads.The patient wanted to have the cervical system explanted so they are planning to do that.Surgery was scheduled for (b)(6) 2021.The issue was not resolved at the time of the report.
 
Event Description
Additional information was received from a manufacturer representative (rep).It was reported that the cervical ins and leads were explanted as planned on (b)(6) 2021.The ins and leads were discarded by the customer.
 
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
Product id 977a275 lot# serial# (b)(6) implanted: 2017-(b)(6) explanted: 2021-(b)(6) product type lead product id 977a275 lot# serial# (b)(6) implanted: 2017-(b)(6) explanted: 2021(b)(6)product type lead correction made to h6.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.It was reported that the patient had their ins placed in (b)(6) 2017.In (b)(6) 2021, imaging showed that the cervical stimulator leads had broken off and had to be removed in (b)(6) 2021.Two of the fragments were unable to be retrieved and are now loose at c1 and c2.The patient said their hcp says they can never have mri imaging again because of this.
 
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.
 
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Brand Name
INTELLIS
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
MDR Report Key11731756
MDR Text Key247498994
Report Number3004209178-2021-06741
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2018
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received10/31/2021
Date Device Manufactured12/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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