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

Model Number 97716

Device Problems Energy Output Problem (1431); Connection Problem (2900); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 39565-30, serial#: (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 39565-30, serial/lot #: (b)(4), ubd: 29-dec-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).Manufacturer representative (rep) reported they could not insert a previously abandoned lead into ins.Were able to successfully insert other leads with no impedance issues. the abandoned lead was left in the ins pocket of patient.Tried to insert lead into both ports unsuccessfully.Other leads went into both ports successfully.Left original lead configuration. patient has a paddle lead and 2 perc leads existing at time of ins replacement.When intellis was implanted, 1 lead from the paddle and 1 lead from the percs was connected.The patient didn't receive the coverage from the paddle they wanted and requested the other lead be connected in its place during pocket revision.The other lead was attempted but could not be fully inserted into ins.Both ports were tried unsuccessfully.The original lead configuration was left connected properly.The attempted lead had just been sitting in the pocket with a loose anchor covering the electrodes.Cause of issue could not be determined but it appeared that one of the contacts was bent.Lead was left in place.Patient has 1 lead providing desired coverage.Information has been confirmed with account.Issue was resolved.

Manufacturer Narrative

Product id 39565-30, serial# (b)(6), implanted: (b)(6) 2009, 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

Rep reported that reason for pocket revision was because patient was not happy with therapy coverage of 1 lead.

Manufacturer Narrative

Continuation of d10: product id 37712 lot# serial# (b)(6), implanted: (b)(6) 2009, explanted: (b)(6) 2020, product type implantable neurostimulator product id 3778-45 lot# serial# (b)(6), implanted: (b)(6) 2009, explanted: product type lead product id 3778-60 lot# serial# (b)(6), implanted: (b)(6) 2009, explanted: product type lead product id 39565-30 lot# serial# (b)(6), implanted: (b)(6) 2009, 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 was received from the patient reporting they received the medtronic id card that provided information about mri eligibility but he cannot have an mri at all because that is what he was told since he had his first medtronic ins implant.Patient reported he still have the old lead wires from the first implant.Patient reported they haven't used the ins close to 3yrs ago because the leads are not working and the leads were hooked up wrong and the leads are not hooked up to anything so he haven't used or charge the ins.Patient stated they had issue hooking up the leads with the first medtronic ins and then he had a second ins implant from a different company and that company went out of business and that is why they implanted a medtronic ins.Ps reviewed patients have to use the controller to activating mri mode to determine the mri eligibility and patient said he does not have that option.See related rr# 3004209178-2023-05487.

Event Description

Additional information received.Patient reported nothing done to resolve issues.

Manufacturer Narrative

Continuation of d10: product id 37712 serial# (b)(6) implanted: (b)(6) 2009 explanted: (b)(6) 2020 product type implantable neurostimulator.Product id 3778-45 serial# (b)(6) implanted: (b)(6) 2020: product type lead.Product id 3778-60 serial# (b)(6) implanted: (b)(6) 2009 product type lead.Product id 39565-30 serial# (b)(6) implanted: (b)(6) 2009 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.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 11030581
• MDR Text Key: 226537052
• Report Number: 3004209178-2020-22135
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: 00643169781740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2023

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: 05/14/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/17/2020; 04/21/2023; 05/09/2023
• Supplement Dates FDA Received: 12/23/2020; 04/25/2023; 05/19/2023
• Date Device Manufactured: 05/19/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG