MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97716

Device Problems High impedance (1291); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient experienced a shocking sensation which was random and not associated to a specific body position.Palpating the system does not elicit the shocking feel ing.The shocking sensation was only present when the battery was on.Impedances were within range.

Event Description

Additional information received from the manufacturer representative (rep) stated that the reprogramming did not give sufficient pain relief.After looking at x-ray images a new stimulation program was created.The rep has to wait to hear if this helped the patient in reducing the pain.No patient complications were reported as a result of this event.

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

Continuation of d10: product id: 977a2; 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.

Event Description

Additional information was received from the manufacturer representative (rep).The ins implant date was provided.It was reported that the healthcare professional (hcp) would open the pocket on (b)(6) 2021 and try to get the lead out of the ins and try to dry the header of the ins.The cause of the issue was unsure.Additional information was received from the rep.It was reported that the revision procedure occurred on (b)(6) 2021 as planned for the patient's pocket stimulation.The cause could be found in moisture of in the ins header.When reading out the ins, a warning message for an open circuit involving electrodes 12, 13, and 15 was seen.The red do not use impedance status was also shown for electrode 12, but impedance results showed all green status results tested with electrode 15 as the reference electrode with impedance values ranging between 1340-27890 ohms.The lead was removed and cleaned, then plate 4 and impedance for electrodes 8 and 12 were below 2500 ohms.The pocket was closed, but after two hours the patient had the same complaints.The ins was read again, and now impedance testing with electrode 10 as the reference showed red status with out of range impedance above 40000 ohms for electrodes 9 and 12.Due to differential target multiplexed (dtm) programming on program c, programming was changed.A data report was provided, and there was nothing abnormal visible in it.In the rep's opinion, this was not a question of moisture in the header, but more of lead damage at the level of the proximal part that was in the pocket and possibly rolled up.Additional information was received from a rep.It was reported that due to the high impedance on electrode 8 and 12, the rep reprogrammed to skipped bipolar from lead 8-15 to skipped bipolar on the other lead which was placed partially parallel.For the bottom, they left electrode 12 out, and chose electrode 12 and 14.The day after, the rep was informed that the patient still experienced pocket stimulation.The rep thought that they should consider abandoning lead 2 and trying to use only the left lead then check if this resolves the pocket stimulation.

Manufacturer Narrative

Continuation of d10: product id 977a2, serial# unknown, implanted: (b)(6) 2021, 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 from the rep.It was reported that the revision procedure performed on (b)(6) 2021 was an attempt to resolve the high impedance on electrodes 8 and 12 as it was believed that fluid in the header was causing these impedance values and the associated pocket stimulation.At first this seemed to help but later that day the patient reported the pocket stimulation again, therefore it was decided to reprogram the therapy using electrodes with in range impedance measurements.With this new program the patient did still feel the pocket stimulation while the impedance of the used electrodes seemed to be in normal range.On (b)(6) 2021, a new programming session occurred where the programming only used electrodes 0-7, abandoning the 8-15 electrodes lead.The serial number of the lead was unknown and it could not be determined which serial number of the ones implanted was the affected lead.The implant date of the lead was provided.

Manufacturer Narrative

Product type lead product id 977a260 lot# va2cca7023 serial# 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.

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 received from the manufacturing representative reported that the new program did resolve the patient¿s pain issues to an acceptable level.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12259652
• MDR Text Key: 264518540
• Report Number: 3004209178-2021-11749
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 08/12/2021; 08/17/2021; 09/12/2021; 09/27/2021
• Supplement Dates FDA Received: 08/11/2021; 08/16/2021; 08/18/2021; 09/13/2021; 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention