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); Communication or Transmission Problem (2896)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6) product type recharger product id 97745 lot# serial# (b)(6) product type programmer, patient 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) 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 regarding an external device.The reason for call was patient said the buttons were sticking really bad on the controller and patient had a hard time getting them to work.Patient mentioned they still had response to the buttons, but they had to push the button multiple times.Patient also said a lot of times an error would come up while recharging and patient would have to keep trying to recharge over and over again.Agent asked, patient did not remember the error code.Patient confirmed both issues started months ago, confirmed sometime last year.A replacement controller was sent out.Agent reviewed if error message continued with replacement controller to capture details and call back.Pt called back and repeated previously documented information; difficulty charging ins.Pt noted they were unable to charge the implant and kept getting 'no device found' while using recharger and the cord would get hot.

• 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: 19003168
• MDR Text Key: 338924183
• Report Number: 3004209178-2024-08098
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/29/2024
• Date Device Manufactured: 03/08/2019
• 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: 37 YR
• Patient Sex: Male