MAUDE Adverse Event Report: INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems High impedance (1291); Energy Output Problem (1431); Application Program Problem (2880)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

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 manufacturer representative (rep) regarding a patient who was implanted with an implantable neurosti mulator (ins) for spinal pain.It was reported that the rep was trying to program the patient and they were seeing high impedance values on the impedance test results.Prior to calling, the first time the caller checked impedances the electrodes 11 12 13 were out of range with the do not use indicator.The caller tried to program using electrode 10 was getting oor when increasing intensity.The rep re-ran impedances and the results showed that 10 12 and 13 were out of range.During the call the caller provided the following values from the impedance test values: ref (b)(4).The rep indicated that they were only able to get therapy coverage on the patient's left side.The issue was not resolved through troubleshooting.Technical services reviewed information about impedances.The rep was going to continue to try programming with the patient.

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 manufacturer representative (rep) reporting that after speaking with tech services they were told that changing impedances for different electrodes on the same lead was consistent with a possible lead fracture.It was reported that the patient wanted to keep their stimulation programming because they were content with the therapy they were getting at the time.The rep reviewed the possibility of a lead fracture with both the patient and the implanting physician.The physician instructed the patient to notify the rep if there were any changes in therapy at which point they would explore a lead revision.The rep indicated that the patient was asked their weight at the time of the event, but the patient did not know their exact weight.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.A manufacturer representative (rep) called in later on (b)(6) 2021, reporting that they were following up on a case for which he checked the patient's device today.The caller indicated that they tested impedances and 5 contacts showed the red indicators with va lues >40000ohms.The caller provided the following values: 8 1120ohms 9 1300ohms 14 1450ohms 10 11 12 13 and 15 were all high during the appointment today.The caller indicated that a report was submitted previously by a colleague.That report included that electr odes 11 12 13 were out of range 10 was causing oor to be displayed.The caller asked about potential causes of high impedances.Technical services (tss) reviewed information.The caller will follow-up with the patient and hcp.

Manufacturer Narrative

Continuation of d10: product id 977a275 lot# serial# (b)(6).Implanted: (b)(6) 2021.Explanted: product type lead product id 977a275 lot# serial# (b)(6).Implanted: (b)(6) 2021.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 received.Rep reported the patient and his physician are considering a lead revision.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• MDR Report Key: 12460902
• MDR Text Key: 271058744
• Report Number: 3004209178-2021-13727
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10"
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR