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

Model Number 97715

Device Problems High impedance (1291); Low impedance (2285); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/08/2024

Event Type  malfunction  

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

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that the stimulator is not working properly and pt is not getting relief since implant.Patient stated they talked to the rep last tuesday and they said they thought one of the wires was bad.Patient stated the rep told him they will set up apt to do an x-ray to make sure the leads are in tact.Patient stated they can feel tinging in the feet and the implant is on but pt is not getting relief.Patient services specialist asked patient to connect with the controller and controller show implanted neurostimulators 100%, controller 90% charged.Patient service asked if patient is able to adjust the stimulation and patient said no, the device is locked.Agent asked patient to navigate the controller and setting is group a, p1, p2.Agent asked patient to increase the stimulation and patient said the controller is showing message settings not available message cannot provide your desire intensity on the controller since last week.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Agent sent email to local reps.On 2024-02-06 additional information was received from the manufacturer representative (rep).Rep referenced this case where 'settings not available' was noted.Caller noted that the pt does have a contact since implant that is 'yellow' when doing an impedance check.The caller wanted to know why a contact would show yellow--agent reviewed impedance checks and what the green/yellow/red actually indicate and reviewed the importance of referencing the contact pairs he is actually using in programing, particularly when encountering 'settings not available.' on 2024-feb-28 additional information was received from the rep.Telemetry and impedance readings report was provided.High impedance of 40,000 ohms was reported, with electrodes noted as do not use and avoid.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information from the rep indicated that the impedances were low.There were no abnormalities found with the x-rays.Cause of impedance issue was unknown.The patient was reprogrammed and bilateral foot coverage was obtained.The concern is currently resolved.Patient weight is unknown.

• 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: 18811559
• MDR Text Key: 337626164
• Report Number: 3004209178-2024-06027
• Device Sequence Number: 1
• Product Code: LGW
• 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: 04/01/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/01/2024
• Date Device Manufactured: 11/29/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male