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

Model Number 97715

Device Problems Energy Output Problem (1431); Application Program Problem (2880); Data Problem (3196)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.It was reported that she cannot get her settings correct - pt clarified the settings that pt was given at her last programming appt were to high so she went to a different group but she cannot adjust the stimulation up or down.Pt reported error message "settings not available" after pt changed it a few days ago.Pt stated she saw a rep a few weeks ago for programming changes and pt stated that she could not use that programming because stim was too high. patient services is sending a message to the local field rep about pt call.And error message.Additional information was received from the patient.Pt called back and said that they spoke with the rep and they said to call ps.Pt said that they are still seeing "settings not available" on their controller.Pt said that their settings also changed after they charged their implant about a week ago.Pt said the settings are too high, so they changed the settings themselves and the changes they made went away after charging the implant.Pss had pt reset their controller.Pt had assistance on the call with this.There was no visible damage to the controller contacts or port.There was also no visible damage to the recharger.Pss sent email to repair to replace the recharger.Pt will call ps if issue persists after replacement with settings changing after charging their implant.Pss also redirected pt to hcp and emailed reps for visibility regarding the issue.Additional information was received from a manufacturer representative (rep).Pt was supposed to have an appointment on (b)(6) 2022 and they cancelled.The rep noted the patient had either the battery and/or a new controller sent by patient services.

Manufacturer Narrative

Continuation of concomitant medical products: product id 97755, serial# (b)(4), product type: recharger, date of event: date is approximate.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 was received.It was reported that the controller needed to be reset to resolve the settings changing on their own.The circumstances that led to the settings changing on their own, stimulation being too high, and the settings not available message were that the medtronic settings were too high.The patient noted that the steps taken to resolve the issues were that medtronic called the patient and gave them instructions on how to reset the settings; the problem has been resolved.

• 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: 14919022
• MDR Text Key: 303584287
• Report Number: 3004209178-2022-08462
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2022
• Date Device Manufactured: 08/02/2019
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 109 KG