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); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id m995402a001 lot# serial# (b)(6) implanted: explanted: product type product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (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 reported that the controller was not working anymore; would not allow them to charge the controller or implanted battery.Agent asked event date, and pt said the issue started "just lately." patient stated that they talked to medtronic representative over the phone a few days ago about the issue and was instructed to reset the controller, which was when they realized something was sticky/leaking from battery on the side with the sticker.Patient did not see any visible damage to, or residue in, the controller battery compartment, controller port, nor recharger plug.The issue was not resolved.An email was sent to the repair department to replace the battery pack.Additional information received from the patient.Pt called back from number registered saying they got the replacement battery pack, but still they couldn't charge their implant.Pt described the screen would go around on looking for a device and then not start charging.Agent reviewed trying to start charging during the call for troubleshooting/to clarify what was happening, however when patient went to grab the recharger, they said they had to go and would call back.Caller mentioned controller issue from original call and that controller was unresponsive but this resolved once controller was plugged into the wall without the battery pack.Since around the same time, patient had noticed the recharger wasn't connecting to the ins and the recharger was getting warm at the cord/paddle connection.Caller met with patient today and attempted passive recharge cycles as the ins was depleted but received all 0s on the antenna locate screen.Caller used another recharger they had and they were able to complete passive recharging to see normal charging screen with excellent connection.Ins was currently charged to 30%.Tss emailed repair for replacement recharger.

• 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: 19158734
• MDR Text Key: 341502686
• Report Number: 3004209178-2024-09546
• 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: Recall
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2024
• Date Device Manufactured: 06/24/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Female