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

Model Number 97715

Device Problems Corroded (1131); Failure to Interrogate (1332); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996); Data Problem (3196)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name intellis; product id 97745 (serial: unknown); product type: 0201-programmer patient 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.It was reported that the patient had lost controller and then on friday they tried to charge controller they say the screen only comes on when ac power cord is plugged in.They took the battery pack out and says they can't read the serial on the inside of the controller because they say the sticker is peeled off but read serial of the battery pack.During the call, the pt took the battery out and plugged in ac power cord and screen came on.They put battery pack back in and got the memory problem screen.Pt set day and time.They will charge up controller and will then try to charge the implantable neurostimulator (ins).Ins may be discharged and pt might be calling back in for help using passive recharge mode. patient called back and reported that the controller goes unresponsive after unplugging it from the wall charger.When the patient would connect the controller to the recharger nothing would happen.When they connect the controller to the wall charger again the set up screen displays.Patient inspected the controller and found the battery compartment pins were corroded and the sticker that had the serial number was scratched.Patient mentioned their hands hurt so bad because of not being able to charge the implant.The implant was "dead" for 3 months.The patient was unable to charge the implant due to the formerly missing controller.A replacement controller was sent out.  additional information was received from a patient (pt).It was reported that they can't get the controller to find the implant.Patient stated the implant hasn't been charged for 3 months.Patient noted the controller was still in the set up process.Agent attempted to walk patient through set up, but patient kept seeing no device found.Agent walked patient through entering passive recharge mode.Patient confirmed they were recharging with excellent quality with the controller at 90% and the implant in the red.Agent reviewed finishing the set up process after the implant had charged.Agent reviewed everything was working as intended.

• 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: 18940005
• MDR Text Key: 339048693
• Report Number: 3004209178-2024-07405
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 07/01/2019
• 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 Age: 66 YR
• Patient Sex: Female