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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

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.Patient stated starting probably a few weeks ago, their stimulator keeps turning off on it's own.Pt said they wouldn't have turned ins off, but all of a sudden they would be hurting again and so they would check controller and controller would say stim needed to be turned on.Pt said recently had would check to make sure stim was on in the morning as stim is usually off when they wake up.Pt said now they would just be walking around the house and notice stim wasn't right so they would check controller and noticed stim was turned off.Pt said ins would still have some charge when the issue happened and they don't have adaptivestim programmed in.The circumstances that led to the reported issue were asked but unknown.The patient was redirected to their healthcare provider to further address the issue.Pt said they had not seen a doctor for their device, but would try to follow up with their hcp.Patient was directed to take notes when stim turned off on it's own to gather more information.

Event Description

The patient reported that they were pushing the wrong button which caused the stimulation to shut off.When they would press the top button on the patient controller, it would display that stimulation was turned off.The patient spoke with a manufacturer representative who helped troubleshoot and resolve the issue.

Manufacturer Narrative

H6 coding has been updated to reflect the new information received.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: 12532674
• MDR Text Key: 273330061
• Report Number: 3004209178-2021-14423
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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: 09/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 12/01/2021
• Date Device Manufactured: 09/29/2020
• 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
• Patient Age: 85 YR
• Patient Sex: Female