MAUDE Adverse Event Report: MEDTRONIC INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Computer Software Problem (1112); Overheating of Device (1437); Use of Device Problem (1670); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id: 97755, lot# serial#: (b)(6), 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), udi#: (b)(4), h3: analysis of the 97755 recharger (rtm) (serial number (b)(6)) revealed no device found message.Scrapped.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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that reason for call was caller states this am was trying to charge said excellent and 20 min later said red x software problem cannot continue please call medtronic.1) i ntellis 2) 3.6 3) 58 4) qf_new pss advised to reset controller.Pt mentioned she needs both shoulder blades replaced so hard to get rtm in place correctly.The troubleshooting steps that were taken on the call resolved the issue.Pt called back from number registered reporting information recharging issues.Pt stated they tried and tried and tried again and finally gets recharger (rtm) recharging antenna in place to charge their ins battery.Pt commented that it looked fine for about 10 minutes and then would "crap out", so once or twice again they removed the battery (li bp) and tried again.Pt said instead of it (recharge session)just stopping they got the following message system problem rm03; call medtronic.Pss began troubleshooting by asking pt if rtm recharging antenna gets hot when recharging ins and pt replied "yes, it did today but it never has before." pt mentioned being frustrated with having a really hard time getting the recharging antenna in place (back behind them where the ins battery is located) because they need both shoulder joints replaced (pss noted pt reported shoulder issues to agent in case earlier).Pt said their shoulders are killing them today.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC; unknown
• Manufacturer (Section G): MEDTRONIC; unknown
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18192563
• MDR Text Key: 328969773
• Report Number: 2182207-2023-02556
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• 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 H10...."