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

Model Number 97715

Device Problems Intermittent Continuity (1121); Disconnection (1171); Failure to Deliver Energy (1211); Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Application Program Problem (2880); Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported they need to be reprogrammed.Pt reported they were at a physical therapy appointment for their hip sometime around (b)(6) 2021 and their physical therapist was stretching pt's knee to their chest and their device "went crazy".Pt stated they could feel stimulation up into their arm pits and down the sides of their legs.Pt stated they were programmed with 3 different groups so they tried changing groups to see if that would help and it didn't.Pt stated they were reprogrammed by a manufacturing representative (rep) sometime around the end of (b)(6) 2021 and the reprogramming didn't help.Pt stated after being reprogrammed their symptoms are not being relieved and they feel the same whether or not stimulation is turned on or off.Pt noted that rep reprogrammed them so their rate was 1000 and intensity was 7.Pt also mentioned that "settings unavailable" displays on their controller ever since being reprogrammed and their stimulation has been turning off by itself.Pt commented that this is their second device and the therapy has always completely eliminated their pain up until recently and they're able to golf again.Pt also noted that they've had a hip replacement in the past.Pt stated they have an upcoming doctor appointment on (b)(6) 2021 at 9am and would like a different rep to meet them at the appointment if possible for reprogramming.Ps emailed field reps for visibility.Additional information was received from the patient and it was reported that patient called and stated had adjustment and therapy seem ok and after couple days therapy turned off, and when he stand up and walk he felt high rate of stimulation that grabbed him.Patient stated something went wrong during his physical therapy session because he was feeling vibration where he didn't feel stimulation before in the armpits and legs.Patient stated he thinks there is a disconnection and more needs to be done.Patient stated he spoke with two manufacturing representatives (rep)s last week but they don't seem very anxious to help him.Patient asked what does he need to do to get someone to assist him.

Event Description

Additional information received from the patient.It was reported that the patient received two letters from the manufacturer.The patient noted that during a physical therapy appointment, somehow during the process of manipulating their body, something went wrong with their device when performing spinal compressions.X-rays were done, but they saw nothing wrong on the x-rays.Their doctor wanted them to drive all the way to pittsburgh, 3 hours away, for someone else to take a look at their stimulator.They called to get this set up and haven't heard back from anyone and were told someone would contact them a week ago.They have met with three representatives for programming and that has not worked.The patient said that something was broken.The device was not managing their pain and they were sore and the doctor would not give them pain medication.They have tried different combinations of things with rates in their therapy to see if they can get something.They took a fall and have even more pain since then.They would like to talk to a representative again to have them look at their device.They later noted that the controller was at 100% last night and the controller went down to 40% this morning.They connected the controller to the implant and the controller showed that the ins was at 40% and the controller was at 100%.Their ins was on the previous night.It was reviewed that setting and usage would cause the implant to deplete and the patient said the ins did not go down that much before.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 12375408
• MDR Text Key: 268438228
• Report Number: 3004209178-2021-13001
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Date Device Manufactured: 09/09/2017
• 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: 69 YR
• Patient Sex: Male