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

Model Number 97715

Device Problems Therapy Delivered to Incorrect Body Area (1508); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Inadequate Pain Relief (2388)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(64, implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.Product id: 977a260, serial/lot #: (b)(4), ubd: 29-aug-2023, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 29-aug-2023, udi#: (b)(4).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 non-malignant pain.It was reported the trial lead was placed correctly, however since march stimulation would not go up to the patients target area, l1-s1.Around the same time it was determined the right lead had malfunctioned.Programming did not resolve the issue.The patient had their lead replaced, waited 2 weeks, and then had stim turned on last week.The patient only felt stim in left leg, buttocks and down and not in their back or right side at all.The patient had another follow up for (b)(6) 2021.The patient tried a,b,c and tweaked their programs to try and lower their leg stim and increase other areas without success.The patient stated the pain was killing them, they even took a pain pill but still had pain.The patient was redirected to their healthcare provider to further address the issue.

Event Description

Additional information was received from the patient.The patient said they were told from the rep to have the stimulator turned off for 4 to 6 weeks after they tried to set the therapy in the lower back tailbone.The patient was inquiring what they should do now.The patient was redirected back to their rep and hcp to answer their question.

Manufacturer Narrative

Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2020, explanted: (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.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (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 patient.The patient reported that the right lead malfunctions and stopped working in (b)(6) 2020.The lead was implanted on (b)(6) 2020.The patient reported that from (b)(6) 2020 to (b)(6) 2020 before the healthcare provider (hcp) asked what he should be doing and the patient said replace the lead.The patient reported that the leads were removed and new ones were put in.The patient reported that faulty leads led to the issue.The patient reported that the new leads were placed on (b)(6) 2021 and rep still couldn't get them set for low back pain.

Event Description

The patient is upset that their therapy still is not working and they cannot get it above his tailbone.The patient met with a local manufacturer representative who was able tp get the stimulation up a little higher, but the patient still wants another manufacturer representative to take a look at it.The patient is having a morphine injection and a pain pump trial.

Manufacturer Narrative

H10.Additional information regarding manufacturer report#: 2182207-2021-01282 will be submitted as supplementals under this report.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.

Manufacturer Narrative

Continuation of d10: product id 977a260, lot# , serial# (b)(6), implanted: (b)(6) 2020, explanted:(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 from the rep indicated that the patient complains that their stimulator does not give them optimal pain control.States he has been programmed a number of times but nothing compares to the pain relief that he received during his trial.The rep told the patient to reach out to his pain physician to coordinate a follow up appointment and assessment.

• 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: 11596064
• MDR Text Key: 248985868
• Report Number: 3004209178-2021-05251
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/08/2021; 06/10/2021; 07/20/2021; 09/29/2021
• Supplement Dates FDA Received: 04/16/2021; 06/16/2021; 08/09/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 91