Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Malposition of Device (2616)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 01/25/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 97715, serial#: (b)(4), implanted: (b)(6) 2021, product type: implantable neurostimulator.Product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2007, product type: lead.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(4), ubd: 22-feb-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt went into an appointment with their healthcare provider's (hcp) office on (b)(6) 2021 to test spinal cord stimulator(scs) after a replacement surgery for both ins devices that occurred on (b)(6) 2021.The pt confirmed previous ins devices were replaced due to the end of the regular life expectancy.On the (b)(6) appointment, pt mentioned upper scs worked fine, but, when the hcp tested the lower scs, the pt experienced intense therapy.Hcp performed x-rays and found the lead was wrapped around a muscle in the back and lead was in the middle of the back (lead placement not expected).Pt said the hcp "pulled the wire out of pt's spine." on (b)(6) 2021, pt went to another appointment with hcp office to have the lead in the middle of the back replaced with a new lead.Pt mentioned hcp put lead in "same spot" and pt was currently not experiencing therapy on right side of hip, leg, and back.Pt mentioned they were "going through hell" and will not going back to that hcp office.Pt contacted a new hcp office to schedule an appointment.
 
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
The patient reported that they received a follow up letter, so they were responding to the letter.Patient weight was provided.They reported they didn't know which ins was attached to the lead that had wrapped around the muscle since both the ins and lead had already been removed.The issue has not yet resolved.Patient services reviewed the patient would need to see their doctor for assistance to schedule an appointment with a rep to do reprogramming to "fix the ins" so they can have pain coverage on their right side.The field was notified of the patient's request for a reprogramming session.The rep responded stating they would contact the patient.
 
Event Description
Additional information was received from the manufacturer representative (rep).It was reported that the reprogramming session took place on (b)(6) 2021.After the reprogramming session, the patient received coverage to their right side.The issue has been resolved.
 
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

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLIS
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
MDR Report Key12199992
MDR Text Key262653360
Report Number3004209178-2021-11152
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
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received10/07/2021
Date Device Manufactured08/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight85
-
-