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); Charging Problem (2892); Operating System Becomes Nonfunctional (2996)

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

Event Date 03/07/2024

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 intellis; product id 97745bp (serial:(b)(6); product type: 0001-accessory brand name intellis; product id 97755-s (serial: (b)(6); product type: 0213-recharger 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

It was reported that the battery pack was not recharging from the wall.It said to replace battery soon yesterday.Pt had been having trouble with controller going off and coming on and with locking.The issue started about a week ago and got worse yesterday when patient went to charge the implant.The screen went off when pt was trying to recharge the implant.The message to replace battery came up when pt was unplugging the controller from the ac power supply.The controller screen showed a plug on the screen.On the call instructed patient to take the battery out and plug the controller in the wall without the battery.The screen came on.Patient put the battery back in and the green light was not blinking.Pt confirmed the ac power supply had the green light.An email was sent to repair to replace the battery pack. patient called back and stated they are getting a message to install mdt battery pack and try again when they go to charge the ins.Patient stated hcp ofc told them to call for bp replacement again.Agent assisted patient with resetting the controller and inspect the controller and battery for visible damage.Controller powered on and charged to 100% with ins low and there is no visible damage on the bp or controller.Agent asked patient to inspect the rtm for visible damage and patient said there is no visible damage on the rtm.Agent asked patient to plug the rtm into the controller and controller screen went black with no power.Agent reopened the case and sent email to the repair for rtm replacement. pt called back in wanting verification that the piece of equipment being replaced was correct.Agent walked pt through resetting the controller and verified the controller did not go blank once unplugged from a/c cord.Agent reviewed they agreed with the previous agent and that the recharger should resolve the issue.

Manufacturer Narrative

Continuation of d10: product id 97745bp serial# (b)(6).Product type accessory product id 97755-s serial# (b)(6).Product type recharger product id 97745 serial# (b)(6) product type 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

Patient called back and reported controller screen still black while using replacement recharger and bp.Pt called back stating the same info documented earlier and stated they received the controller and it's flashing green.Agent recommended pt charge controller and then charge implant.Pt stated they broke a glass over their old controller but it was working fine for 6 months, agent advised pt to continue using new controller and send back old controller.

• 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: 18986865
• MDR Text Key: 338762779
• Report Number: 3004209178-2024-07902
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Date Device Manufactured: 04/01/2022
• 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: 64 YR
• Patient Sex: Male