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); Therapy Delivered to Incorrect Body Area (1508); Data Problem (3196)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt said they went to bed last night and their stimulation "took off".Pt said it felt like the stimulation increased to a 5 when they were typically at a 2.1 on the left and 2.5 on the right.Pt said they could feel the stimulation all the way down to their foot and back up to their knee so they turned off their stimulation and hadn't turned it back on since 4am.Pss walked pt through checking their stimulation levels, pt was on group a program 1.2.2, 2.2.6.Pt turned the stimulation back on and it was working as intended (pt mentioned it depends on what position they were in for how it feels).The patient was redirected to their healthcare provider to further address the issue.Pt said they have an appointment on the 24th with their hcp.

Manufacturer Narrative

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 from the patient.It was reported that the patient said it seemed as though it had switched to a more powerful setting.They had shut it down and it started normally.The patient said no steps were taken to resolve the issue.The issue has been resolved, however the patient said they have been a little afraid when starting it that it would happen again.

• 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: 13237135
• MDR Text Key: 291747891
• Report Number: 3004209178-2022-00540
• 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: 02/10/2022

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: 01/11/2022
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/10/2022
• Date Device Manufactured: 12/07/2019
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 83 KG