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

Model Number 97715

Device Problems Failure to Interrogate (1332); Overheating of Device (1437); Use of Device Problem (1670); Charging Problem (2892); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain indications.The reason for call was pt mentioned they were trying to charge their implanted neurostimulator(ins) and were recharging excellent, but every few minutes the pt would get "poor recharge quality" since a couple of days ago.Pt mentioned they had to hold very still to charge their ins.During the call, the pt was recharging excellent.Pt inspected the rtm cord and plug and the controller port, but no damage was detected.Pt then attempted to restart a charging session and got "no device found." pt entered passive recharge mode and held the rtm coil toward the center of the room and had 3, 3, 3.Pt then placed the rtm coil directly over the relay box and got 88, 88, 89.Pt then moved the cord and number changed, but were still in the 90's.Pt lifted the cord up towards the ceiling and got 3, 3, 3.Pt then put the rtm coil over their ins and got 93, 96, 99.Pt restarted the charging session and got recharging "excellent." ins charge was low and controller charge was 90%.Pt charged for several minutes, but the recharge quality kept switching from excellent to poor.Pt mentioned they would reposition the rtm and "start all over again." pt mentioned they were sitting in a chair and charging and pt said they were in pain because they could not charge consistently.Pt mentioned they fell real bad on their back about a month ago, but had x-rays of their back and the stimulator and "everything was fine." pt was redirected to hcp to further address the issue.Additional information was received from the patient.Pt reported that when they try to charge the ins it is still doing the same thing, and now the rtm "gets hot".

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 teeth marks on rtm donut, item 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.

• 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: 18242198
• MDR Text Key: 329581370
• Report Number: 3004209178-2023-24779
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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: 75 YR
• Patient Sex: Female