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

Model Number 97715

Device Problems Break (1069); Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 977a260 serial (b)(6) implanted: on (b)(6) 2023 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial (b)(6) , ubd: 14-mar-2027, (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 who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported the implant was not working and the controller was not charging; patient mentioned they got a no device found message on t thursday.Patient got their controller to charge as expected and got their implant to charge but discovered 'setting not available' message on friday.Patient stated the controller would not give intensity settings and patient was not getting any stimulation from the implanted device.Patient reset the controller and the issue did not resolve.During the call patient verified the controller battery was at 100% and the implant battery was 60%.Agent instructed patient to adjust their therapy and patient received settings not available, cannot provide your desired intensity settings.Patient confirmed no other groups available.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Patient called back and repeated information from this case.Patient added that they met with manufacturer representative (rep) on wednesday and it was determined there was a broken lead.

Manufacturer Narrative

Continuation of d10: product id: 977a260, serial# (b)(6), implanted: (b)(6) 2023, product type: lead.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

Additional information was received from the patient.The patient mentioned one lead is broken again and they have to go back to hcp office.Asked clarifying questions and patient said a month and half ago the lead was broke, and a month and six weeks ago was the first time the lead was dead and they met with the manufacturer representative (rep) about the issue.Patient reported they are getting settings not available, cannot provide your desire setting on the controller screen since yesterday.Agent reviewed meaning of the message and recommend patient consult with hcp ofc for next steps.

• 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: 19022372
• MDR Text Key: 339247936
• Report Number: 3004209178-2024-08297
• 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
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/24/2024
• Date Device Manufactured: 07/19/2023
• 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: 59 YR
• Patient Sex: Female