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

Model Number 97715

Device Problems Computer Software Problem (1112); Failure to Interrogate (1332); Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Date 03/04/2024

Event Type  malfunction  

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 #: (b)(6), ubd: , 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 (pt) regarding an external device.The reason for call was patient was having issues charging their ins.Patient stated the controller is not connecting to the recharger very well and will show an error stating cannot continue call medtronic.Patient stated it takes a long time to charge their implant.One of the errors patient saw is software problem 1- intellis 2- 3.0 3-1540 4-app manager.Patient stated they were able to clear that message by resetting the controller.Patient first noticed this issue about 2 weeks ago, and then last friday night it took a very long time to charge, and patient saw the cannot continue call medtronic alert.Patient also stated that the paddle gets very hot when charging their implant.An email was sent to the repair department to replace the recharger.Patient was told to monitor the software error and call back if alert persisted.See email correspondence, pt already called in - see (b)(4).

Event Description

Patients weight obtained.

Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(6)product type recharger h3:analysis of the 97755 recharger (rtm) (serial number (b)(6)) revealed a no device found message.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.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: 19003013
• MDR Text Key: 339886450
• Report Number: 3004209178-2024-08094
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/17/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1535-2021
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 96 KG