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

Model Number 97715

Device Problems Overheating of Device (1437); Charging Problem (2892); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).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).It was reported that the recharger (rtm) is getting very hot and the little box is getting very hot.The rtm was burning the skin and they yanked the paddle off their skin and the patient put ice on the area where the rtm was placed, the rtm caused an indentation mark on the skin but no damage to the skin.Patient stated they are not able to fully charge the implant.It was asked if there was damage on the rtm and the patient said there was coating coming off and its shiny where the rtm and cord are connected.The issue was not resolved.Patient mentioned the manufacturer representative (rep) assisted them with resetting the controller but that did not help.It was recommend that the patient consult with her healthcare provider regarding her concerns.An email was sent to the repair department to replace the recharger device.Additional information was received from the rep.The rep reported that the patient called yesterday (b)(6) 2021 to report the temperature and recharging problems.The rep advised to call in to have their devices replaced.The rep did not know the reason for the problem or if the problem has been resolved.The rep was unaware of any burn problems/charging issues before (b)(6) 2021.

Manufacturer Narrative

Continuation of d10: product id: 97755, serial# (b)(6), product type: recharger.H3: analysis of the recharger (serial# (b)(6)) found that the device was scrapped due to the recharge antenna failure of the no device found message and after failing at plexus and bench testing.H6: b01, c0401, and d01 pertain to the recharger.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
• MDR Report Key: 12130093
• MDR Text Key: 266036279
• Report Number: 3004209178-2021-10486
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2018
• 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 H10...."
• Patient Age: 73 YR