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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.Continuation of d10: product id m995402a001 lot# serial# (b)(6), implanted: explanted: product type section d information references the main component of the system.Other relevant device(s) are: product id: m995402a001, serial/lot #: (b)(6).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) regarding an external device.It was reported that the patient experienced technical di fficulties with the remote for the device implanted in her back.The remote blacked out as if it is dead while fully charged.It was sporadic at first; however, it is now more frequent, and the pt does not receive the support needed and required when the remote is out.Pt stated the pain in my back increases when the remote is out and not providing support.The remote at times blacked out, and pt was unaware. additional information received from patient. pt reported the controller blacks out.Sometimes pt was trying to figure out why they were in pain and realizes the screen was blank and it will reboot itself and would prompt to reset time and date.Sometimes pt reset it or smacked the controller to get it back on.The issue started probably early last year, maybe around march or so.It was sporadic at first and then became frequent.Asked when the pain started.Pt said it was around march or april and hcp told pt to call medtronic.Pt said one day pt was wondering why their back was in pain and realized it was not charging.The controller goes blank not only while charging, it also happened without rtm plugged in.Sometimes the controller blacked out when plugged in the wall.Sometimes pt did not know about it until pt started feeling pain.Sometimes controller was not charging from the wall.On the call pt tried using the controller and it turned on.Pt reset.Pt did not have the ac power supply or rtm with.A replacement battery pack was sent out.

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from a patient (pt).It was reported that their controller was still having issues with charging even with the battery replacement.Patient stated their controller wouldn't charge last night and it keeps going blank.Patient stated after they tried to unlock the controller, the controller shuts off and goes back to "memory problem" message.Additional information was received.Pt states they are trying to pair equipment.Agent advised to reset and pt states they don't have the lith battery and wondered if this was the issue.Pt put battery in and all was working fine.Pt was able to set up and all working fine.

• 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: 18808907
• MDR Text Key: 337623380
• Report Number: 3004209178-2024-06006
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Date Device Manufactured: 12/20/2021
• 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 Sex: Female