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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The patient (pt) mentioned they had been experiencing issues intermittently with their controller and recharger antenna (rtm) since some time ago(when asked about the event date, pt did not provide a specific event date).Pt said they made mdt rep.(b)(6) aware of the issue shortly after receiving the external equipment after implant date(pt did not know notify date).Mdt rep.(b)(6) told the pt to contact patient services (ps).Pt said when charging the implanted neurostimulator (ins), the charging would stop abruptly and the controller would display "finished" even though the charge of the ins was not at 100%.Pt said the controller(or the therapy, pt could not say which one on the call), would turn off abruptly without warning.Pt said they often saw "stimulation is off" but the pt did not turn their therapy off manually.Pt said their pain symptoms returned when the therapy was off.Pt said the charge duration took a long time and seemed like the duration took much shorter when they got it.Pt said sometimes they charged for "hours ," but when they sometimes charged, they would not actively monitor the charge and would realize the charging session of the ins had stopped abruptly without the pt manually stopping the charge session.Pt said they charged without the belt because the belt had broken and sometimes it was difficult to charge if they did not have a pocket in their outfit.Pt said they also saw a "call medtronic" message recently.Pt said after they saw the call medtronic message, they restarted the charge session of the ins successfully without issue.During the call, the pt was charging with excellent charge quality and ins charge was at 70% and controller charge was at 90%.Pt inspected the rtm cord and plug, the controller port, and shook the controller, but no damage was detected.The caller was redirected to monitor the situation and call back if the issue persisted.Pt said they had 4 back surgeries in the past and was hard of hearing.Pt said dr.(b)(6) was their implanting hcp and dr.(b)(6) managed their spinal cord stimulator.Additional information was received, it was reported pt called back from number registered re-reporting information previously documented in this case.Pt said they had called previously because they think their li battery was faulty.Pt said for the last 7-8 months, the "battery/machine" kept turning itself off.Pt said they would start to feel the pain because it was turning itself off.Pt was first describing their stimulation turning off however, pt then said it was the controller display turning off randomly and said they would have to push the on/off button sometimes several times to get the display back on or take the battery out of the controller to reset the device.Pt said now when charging for maybe the last month, the rtm was getting extremely hot on the paddle and relay box and burning their skin (pt was unsure if it left a mark because they haven't gone to look since its on their butt cheek).Pt was adamant that their li battery was the root cause of the issue and would not let ps agent off the phone without an li battery re placement.Pt mentioned they they do not want to keep taking medication because they hurt most at night and cannot live without their ins.Pt said they were on their 4th surgery on their spine.A new controller, recharger and battery pack was requested.

Manufacturer Narrative

Continuation of d10: product id 97755 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 intellis recharger s/n (b)(6) revealed that the rms voltage at the h field probe failed.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: 18240900
• MDR Text Key: 329402443
• Report Number: 3004209178-2023-24762
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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 Sex: Female