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); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Incontinence (1928); Ambulation Difficulties (2544)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

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 they have not been using their device for over a year.Patient stated they stopped using their device in the first week of november or the last week in october of last year, or more than that because they felt like the device was not working.Patient stated that they went to have their stimulator adjusted in the past by a rep and the next day that they woke up, they tried to get up and walk and were unable to.Patient noted that they were in a nursing home and had to wear diapers for over a year; patient followed up saying that they lost a year of their life.Patient mentioned that they do not want to use the device again after that situation.Patient stated that they have an mri of their left hip tomorrow and that they need to have their stimulator turned on and charged.Patient stated that they turned the controller on and they got a screen that had them choose a language and them they were confused on what to select next so they called patient services; agent understood this to be the setup process.Agent walked the patient thr ough finishing setting up the controller; patient was about to pair the controller and implant when they got battery empty charge controller message.Agent reviewed that the patient is going to have to charge their controller and then finish up the pairing process, then they can charge their implant and enter mri mode.Patient asked about charge duration and agent reviewed general use of the equipment with the patient.Patient noted that they do not remember how to use the equipment.Agent advised the patient to charge their controller up and then finish the pairing process; agent mentioned that the patient should call back with any questions or issues with starting a charge session.On (b)(6) 2024 pt called back in and reported their was a software problem that appeared after charging the controller.Agent walked pt through resetting the controller.Pt then needed to set up for implant again.They could not find the device.Agent walked pt through passive recharge mode.Pt was able to exit passive recharge mode and begin charging normally.Agent will call pt back to walk to through entering mri mode. agent called back and pt was able to successfully enter mri mode.

Manufacturer Narrative

Continuation of d10: product id 97745nt.Serial# (b)(6).Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.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 manufacturer representative (rep) reporting that one of their healthcare provider (hcp) accounts got a reference letter and was confused about the follow-up steps.The rep did not currently have the letter in their pos session.The rep said they spoke with the hcp and said the letter was something about how the patient was reprogrammed and it was noted that the hcp or rep had not seen the patient for several months.The patient mentioned difficulties walking, but the rep said the hcp had confirmed disc herniation and the rep speculated that the disc herniation caused the patient¿s symptoms not the reprogramming of the scs device.The rep said pathological changes led to the patient not being able to walk for months.Additional information was received from the manufacturer representative (rep) reporting that the manufacturer representative (rep)¿s knowledge the device was not causal or contributory to the patient¿s symptoms of not being able to get up and walk, being in a nursing home, incontinence, and disc herniation.The cause of these symptoms was not determined to their knowledge.The rep indicated that they were not the rep that made the adjustments for them so they didn¿t know what parameters were changed.The rep was no longer full time with the company.To the rep¿s knowledge the patient did not contact the rep to meet for another reprogramming and did not follow-up with their provider¿s office either.The rep wasn¿t provided information regarding the outcome of the event.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.***mdr decision corrected to not reportable.***.

• 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: 18955522
• MDR Text Key: 338305151
• Report Number: 3004209178-2024-07571
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/03/2024
• Date Device Manufactured: 08/25/2022
• 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 Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female