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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id 97745nt, serial: (b)(6), product type: 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.

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was starting probably a week ago the controller started doing strange things when recharging the ins.It would typically start charging the implantable neurostimulator (ins) but sometimes it took them 5 or 6 times because it would show a round circle and the light above the controller would be yellow not green then it would default to the therapy screen.Today when recharging the ins it said the controller battery needed to be replaced but the controller showed 100%.They would unplug the device and plug it back in; sometimes the controller would not even come on and start the process so they had to reset the controller but issues still persisted and they have done that two or three times.During call pt verified no damage to the recharger (rtm) or to the controller charging port.Pt blew into the controller charging port and reset the controller.Pt then attempted to recharge the ins and it showed the main therapy screen so pt unplugged the rtm and plugged it back into the controller and got recharging excellent.The issue was not resolved.An email was sent to the repair department to replace the rtm. patient was escalated.Controller turned white when charging the implant.Agent reviewed replace controller batteries multiple times.Patient was charging the implant for 54 minutes and implant was at 30%.

• 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: 18979360
• MDR Text Key: 338611258
• Report Number: 3004209178-2024-07833
• 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: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 07/20/2021
• 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 H11...
• Patient Age: 79 YR
• Patient Sex: Male