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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Loss of Data (2903); Insufficient Information (3190); Data Problem (3196)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).It was reported that their stimulation would shut off by itself and the issue began in october. patient would not get a reading when they would open up the controller.Patient couldn't connect with a medtronic representative.Agent was about to review options to connect with a medtronic representative for readjustment but patient got escalated and requested to speak with another agent.Agent was unable to ask more details regarding representative information.Patient stated they needed an mri and their leads were old.Patient also stated they had 3 medtronic spinal cord stimulators and when agent reviewed with patient that there was one previous spinal cord stimulator, to agent's understanding patient was confusing their interstim and spinal cord stimulator devices.Patient stated that the previous spinal cord stimulator 'died'.Due to the nature of the call agent was not able to ask further information.Agent put the patient back in queue since pa tient did not want to wait for a call back. patient the stimulator is not working properly and is unable to connect.Patient mentioned the implant is not adjusting properly and implant goes down to zero then implant does not remember settings.Patient mentioned their pain has increased of the year.Patient stated they had a ct scan and that shows they have additional pain in the middle of their back.Patient stated they adjust the stimulation up to 7 and the implant shuts off. controller is draining and implant not charging.Patient mentioned taking a very long time to charge the implant.Patient mentioned difficulty connecting to implant.Agent instructed patient to start a charge session; controller shows 100% ins dead with recharge excellent quality.Patient stated their recharger belt was flimsy and was using the belt during the call.Patient would like to get reprogrammed but the mdt rep is far.Patient mentioned they have been working with mdt a manufacturer representative (rep) and has been in contact with them often.Patient mentioned they have an appointment and will be meeting with another mdt rep in 2 weeks.A replacement recharger (rtm) was sent out.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.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.

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 regarding an implantable neurostimulator.The reason for call was patient stated they have been in a different kind of pain for a long time.Pt stated they needed the ins to be programmed for some time.Pt stated having issues with the implant and stated pt had two different paddles and the ins cuts off periodically and 5-6 months ago the system reset and doesn't remember what was set on.Pt states lower back pain has been getting increasingly worse the past few months.Patient went to meet the representative one night and when they got there the battery had died so the representative could not get into it.The last time they met with the representative was a year ago and the representative wanted them to drive 2 hours to meet them.Pt states she will charge to wall and at times will take all night to charge.Agent had a hard time clarifying if issue with the equipment and pt reported the new pain they are having and would like the ins checked and adjusted.Pt stated having been in pain and had to ask for more pain meds and had epidural recently.Pt stated their new mid back pain one year ago and lower back pain the past few months.Pt stated they wear a back brace.Pt states spoke to a rep a couple weeks ago and they said they would connect the pt with a representative from another area.Pt spoke to their doctor about it and they can't adjust it for them but pt knows there is something wrong with this.Patient service specialist asked if patient has tried changing groups or anything and patient said no.Patient said they have not tried increasing stim beyond 7.5v.Pt states helps some.Pt states she will attempt to increase the stimulation.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Agent had a hard time clarifying event date.Pt stated last few months.Agent emailed the reps for visibility.

• 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: 19002854
• MDR Text Key: 339219326
• Report Number: 3004209178-2024-08091
• 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,Followup
• Report Date: 04/26/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/26/2024
• Date Device Manufactured: 05/31/2018
• 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: 74 YR
• Patient Sex: Female