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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Overheating of Device (1437); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an external device.It was reported that when recharging the ins the pts controller froze up and did not do anything.They reset the battery and they still got the screen stimulation off and on and lock controller.The pt had trouble for the last two or three days.The controller battery was not holding a charge when recharging the ins and they tried to charge the ins and the relay box was getting warm the last couple days; warmer than normal.During call pt reset the controller but they could not get past the press and hold to unlock screen for it was frozen.The issue was not resolved.  pt noted their stimulation was off and was in pain.A replacement controller was sent out. patient called back reporting that they received their replacement package but that they did not receive the controller.During the call the patient found the controller in a hidden compartment.Patient stated that they are charging the controller. pt called back stating that they couldn't get their ins to charge.Pt thought that they maybe selected something wrong during the pairing process with the replacement controller.Pt said that they couldn't turn the controller on or off.Agent had the pt reset the controller.Agent began walking the pt through the pairing process, however pt saw no device found appear.Agent had the pt tap recharge to go through passive recharge, however pt saw the three numbers as 0 0 0 on the trying to recharge screen.Repositioning the recharger only got the number up to 7.Pt noted that on the old controller they could get the number as high as 98.Pt then reported that the recharger relay box was getting really hot.Agent reviewed recharger replacement with the pt.Pt said that they would have to go another day of being in pain.A replacement recharger (rtm) was sent out.

Manufacturer Narrative

Continuation of d10: product id 97745, serial# (b)(6).Product type programmer, patient product id 97755-s, serial# (b)(6).Product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755-s, serial/lot #: (b)(6).H3.Analysis was performed on [serial/lot #: (b)(6)] analysis found that there was a recharge antenna failure, got hot after running it at the donut end cable.It was also noted the cable insulation is peeling away at bottom of strain relief and wires are exposed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19196535
• MDR Text Key: 341370513
• Report Number: 3004209178-2024-09878
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• 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 H11...."
• Patient Age: 67 YR
• Patient Sex: Female