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

Model Number 97715

Device Problems Computer Software Problem (1112); Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190); Data Problem (3196)

Patient Problems Ambulation Difficulties (2544); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(6), udi#: (b)(4).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

Information was received from a patient (pt) regarding an external device.97745 nld096608n 97745bp the reason for call was last night the pt was recharging the ins battery last night then got software problem 1.Intellis 2.3.6 3.1546 4.Appmanager.C during call pt reset the controller the troubleshooting steps that were taken on the call resolved the issue.Patient called back and stated that last night their controller popped up with an error message to call medtronic and then went blank.Patient stated they think it was the same message they saw last time they called, but they can't remember all the details.Patient noted the controller has been acting up for about a week now where it will come on and off several times.Patient noted that one time they were walking across the parking lot and it kicked on to high gear and they could barely walk.Agent understood patient was referencing the stimulation coming on and off and asked patient to clarify; patient stated it happens completely randomly and not in relation to any positions or activities but noted that if they lay back they get really jolted.Patient stated they don't even know if the stimulation is on now because the controller won't come on.Agent walked patient through removing the battery pack and plugging controller into the ac power cord; confirmed controller powers on.Patient inserted the battery pack and confirmed controller is 0% and implant is 80%.Patient confirmed the controller was recharging and stimulation is on.Patient noted that they used to ad just the intensity levels with 0.2 increments but now it's 0.1 increments.Patient noted they don't want to be in a situation where the controller is unresponsive when they need to change their settings.An email was sent to repair to replace the controller.

Manufacturer Narrative

Correction: g3.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

Information was received from a patient (pt) regarding an external device.97745 nld096608n 97745bp the reason for call was last night the pt was recharging the ins battery last night then got software problem 1.Intellis 2.3.6 3.1546 4.Appmanager.C during call pt reset the controller the troubleshooting steps that were taken on the call resolved the issue.Patient called back and stated that last night their controller popped up with an error message to call medtronic and then went blank.Patient stated they think it was the same message they saw last time they called, but they can't remember all the details.Patient noted the controller has been acting up for about a week now where it will come on and off several times.Patient noted that one time they were walking across the parking lot and it kicked on to high gear and they could barely walk.Agent understood patient was referencing the stimulation coming on and off and asked patient to clarify; patient stated it happens completely randomly and not in relation to any positions or activities but noted that if they lay back they get really jolted.Patient stated they don't even know if the stimulation is on now because the controller won't come on.Agent walked patient through removing the battery pack and plugging controller into the ac power cord; confirmed controller powers on.Patient inserted the battery pack and confirmed controller is 0% and implant is 80%.Patient confirmed the controller was recharging and stimulation is on.Patient noted that they used to ad just the intensity levels with 0.2 increments but now it's 0.1 increments.Patient noted they don't want to be in a situation where the controller is unresponsive when they need to change their settings.An email was sent to repair to replace the controller.

• 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: 19003564
• MDR Text Key: 338904243
• Report Number: 3004209178-2024-08113
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 10/22/2018
• 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 H11...."
• Patient Age: 88 YR
• Patient Sex: Female