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

Model Number 97715

Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Insufficient Information (3190)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.Continuation of d10: product id 97745 (serial: (b)(6)); product type: 0201-programmer patient; implant date n/a; explant date n/a product id 97745bp (serial: (b)(6)); product type: 0001-accessory; implant date n/a; explant date n/a section d references the main component of the system.Other medical products in use during the event include: 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

Information was received from a patient regarding an external device.The reason for call was patient reported it doesn't seem to be working right.Patient stated when they go to bed it takes forever to find the device.Patient said they get excellent recharge quality but still would not charge the implant.Then at one point the controller said they needed new batteries.Patient reported last night the controller screen went completely white.Patient reset the controller and the screen came back on.Patient noted they had the controller on for 2 hours and the implanted neurostimulator was only 30% charged.During the call patient verified no damage to the recharger or to the controller charging port.The issue was not resolved.Patient called back in and reported that after receiving their replacement controller the recharger was getting hot and they were still having issues recharging the implant.Pt also noted that their battery pack was no longer holding a charge like it used to and they have to charge daily when before it would last 3 days and it will not charge up fully.

• 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: 19204729
• MDR Text Key: 341717121
• Report Number: 3004209178-2024-09951
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Date Device Manufactured: 08/19/2018
• 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: 79 YR
• Patient Sex: Male