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); Failure to Power Up (1476); 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 Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 97745ac, product id: 97745, serial (b)(6), (b)(4).B3: event date is not known.Please see b5 for approximate date range, if applicable.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's representative regarding an external device.The reason for call was caller reported that the controller is not charging since "2-3 days ago on a friday".Caller did not have equipment with them at the time of the call.Agent reviewed they will need to call back with equipment for further troubleshooting.Patient (pt) rep called back stating they received controller replacement from this case but is unable to charge the implant.The controller shows 100% but is not recognizing when the recharger is plugged in.Pt rep reported wear and tear to the recharger from folding the recharger.Agent sent email to repair to replace the recharger.Caller reports the controller will not charge to the wall.Agent advised to reset equipment and when plugging controller to wall does not power on.Agent advised to try aa batteries and call states to just send controller and the ac power.Agent sent request to repair for ac power and the controller to be shipped.Caller states the patient is in pain because she cannot use equipment.Patient (pt) rep called back stating they received controller replacement from this case but is unable to charge the implant.The controller shows 100% but is not recognizing when the recharger is plugged in.Pt rep reported wear and tear to the recharger from folding the recharger.A replacement recharger (rtm) was sent out.

• 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: 19126765
• MDR Text Key: 340453590
• Report Number: 3004209178-2024-09259
• 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: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/17/2024
• Date Device Manufactured: 01/17/2019
• 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
• Patient Sex: Female