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

Model Number 97715

Device Problems Overheating of Device (1437); Use of Device Problem (1670); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that it is taking forever to charge the implantable neurostimulator (ins).The patient (pt) reported they are getting this "triangle message" (pt could not provide message details) it will start charging and then go back to the triangle screen.Pt stated he is resetting the controller when he gets this message.The pt stated the recharger won't go to "excellent" and only shows "good".The pt stated it takes him 1.5 hours to charge the ins. the pt is seeing "looking for device" message and it may go quick and connect to the ins or other times he has to keep repositioning the recharger (rtm) paddle.The pt stated it is hard to find the position to get excellent connection anymore.The pt tried to connect to charge the ins and saw "reposition recharger" message.The pt selected "recharge", passive recharge mode initially showed all 99's and the all 100's; pt moved the antenna off the ins site and it showed 69 - 90%.The pt stated he had just charged the ins to 90% today.The pt connected to the ins with excellent quality and is showing 90% for the controller and 100% for the ins.The pt verified no visible damage to the rtm cord / plug.The pt thinks the rtm is overheating because it is getting "hot" during recharge and he can feel the ins getting an "irritating heat".The pt stated it does not do this all the time.The pt verified he does lay down on the rtm paddle to charge because that is how he can recharge the fastest.The issue was not resolved.A replacement recharger (rtm) was sent out.Additional information was received from the patient (pt).It was reported that pt called back saying they got the new recharger, but every time they plugged in the recharger, the controller screen would go black so pt would have to reset controller.Pt then said they tried to press the top white button, and the button disappeared inside the controller.No symptoms were reported.A replacement controller was sent out.

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6) , ubd: , udi#: h3.Analysis was performed on [product id 97755 lot# serial# (b)(6) ] analysis found that the complaint was unverified.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: 18694881
• MDR Text Key: 336421018
• Report Number: 3004209178-2024-04532
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• 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: 64 YR
• Patient Sex: Male