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); Overheating of Device (1437); Failure to Power Up (1476); Delayed Charge Time (2586); Application Program Problem (2880); Battery Problem (2885); Charging Problem (2892); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was that the controller had been having a hard time going from turning the controller on and plugging the recharger (rtm) into the controller to getting to the recharging part.Pt stated that every once in awhile, the controller would say batteries low and to replace the controller battery soon even though the controller battery would be charged to 40%, 60% or even 80%.Pt stated that the controller screen would go dark and that they would have to reset the controller in order to get the controller to work again.Pt stated that the controller screen would go bright to where they couldn't see anything so they would have to reset the controller.Pt stated that settings not available would also display out of the blue.Pt stated that when the equipment was working good, the ins would recharge from 30% to 100% in less than an hour and that now it was taking two and a half to three hours for the ins to recharge from 30% to 100%.Pt confirmed that all of the issues happening when the rtm was connected to the controller and when they were trying to recharge the ins.Pt confirmed that there was no apparent damage to the rtm and that the rtm does not get hot while recharging the ins; pt stated that the rtm would get warm but not hot.Pt stated that it seemed like the external equipment would last for 3-4 years or more when they first got the ins, however now it seemed like the controller was going bad within 2-3 months.Pt stated that they would be sent a replacement rtm, however the same thing would happen.Pt stated that the controller would be replaced then and that the equipment would work for awhile before the equipment would stop working again.Pt stated that it was probably a month and a half ago when the issues first started.The patient was sent out a replacement recharger (rtm).No symptoms were reported.  additional information was received from a patient (pt) regarding an external device.  pt called back from number registered re-reporting information previously documented in this case.Pt said they received the rtm replacement and they were still experiencing the same issues.Pt said as soon as they turn on their controller, the settings not available screen displays and they then take the battery out of the controller to reset.Pt said they then try to recharge and receive the batteries low, replace controller batteries soon message when the controller was at 80%.Pt was frustrated with the replacement process as they mentioned they call with an issue, get the rtm replaced which doesn't resolve their issue and have to call back for a controller replacement.Patient services (pss) reviewed replacement procedures with pt, pt was escalated and said that something needs to change.Pt said this was the 3rd or 4th time that they had gone through this process. the patient was sent out a replacement controller.No symptoms were reported.  additional information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).  pt said that they received their controller replacement, but are still seeing "settings not available" when they try to increase their intensity settings; pt said this message started appearing last weekend on they think saturday.Pt also said that when they go to menu on their replacement controller, they don't see the "check position" option available for adaptive stim.Pss had pt go to their group b, program 1.Pt said that their adaptive stim was showing off.Pt turned adaptive stim back on, went to menu and was able to see the "check position" option.Patient services (pss) sent email to medtronic reps for visibility on "settings not available" appearing on the pt's controller and redirected pt to hcp.Additional information received from the patient reported that the circumstances that led to the "settings not available" message is that they had gotten the setting not available and the batteries was low when the controller was at 80% and the implant was at 60%.The patient reported that they went to the pain clinic and did a reprogramming and it now working.The received a paddle and a controller.

Manufacturer Narrative

Continuation of d10: product id 97755, serial# (b)(6).Product type recharger product id 97745, serial# (b)(6).Product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6) ; product id: 97745, serial/lot #: (b)(6) , udi#: (b)(4).H3.Analysis was performed on [product id: 97755, serial/lot #: nlf126151n] analysis found that the complaint was unverified.H3.Analysis was performed on [product id: 97745, serial/lot #: (b)(6).There was a main board failure.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 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: 18797058
• MDR Text Key: 337625172
• Report Number: 3004209178-2024-05883
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1535-2021
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Age: 76 YR
• Patient Sex: Male