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); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that patient (pt)â has been in pain since the day of their implant but that this pain didn't happen until they got home that night and they couldn't even walk with the pain; pt said that the first time "she did whatever in the office" they "felt wonderful, no pain, no nothing like i was floating".Pt said that they are taking 2 tylenol in the morning and 2 tylenol at night.Pt also said that today, they feel like their implant was moving and that the implant was right next to their spine.Pt said that there was swelling there too, but the swelling has gone down and pt thought maybe that is why the implant was moving; pss understood the pt was describing swelling around implant site.Pt also was very confused about how to use their external equipment; pt said they felt "stuck"; pss understood that patient felt "stuck" because they were confused on how to use their controller and their recharger antenna for charging their implant.Pss reviewed charging information with the external equipment to the pt.Pt said that they charged their controller last night and put the "paddle" on their back and "it" wouldn't connect; pt stated they were confused at this point in the call.Pss then reviewed charging information with the pt again.Pt mentioned they were putting the "implant" on their back and trying to sleep with "it"; pss understood this as putting the recharger antenna on their back while sleeping.Pss reviewed best charging practices with the pt.Pss then reviewed with pt on how to tell if their stimulation was on; pt said that their controller displayed group a and that group a was lit up in green (stimulation on).Pt said that their implant battery was at 100% and their controller battery was at 100%.The patient was redirected to their healthcare provider to further address the issue.Pss also emailed medtronic reps for visibility (see case (b)(4) for email that was sent).Pt also spoke with another ps agent this morning prior to this call and pss referred to that call (see (b)(4)) for the pt contacting the medtronic rep, (b)(6) (last name unknown). â patientâ stated they couldn't get the rtm on their back, and when they did, "it's not connecting".Pt mentioned they "just got this" yesterday (pss understood as the pt's device was set up) and no reps have called the pt yet to check in.Pt said the first time they used the device "they" (pss understood as the reps) were with them and it was wonderful as the pt was painfree, but now pt had been trying to use the device on their own last night and today, but can't connect.Pt mentioned the batteries were fully charged, but they couldn't connect.Pt indicated they had the rtm plugged in, pss had pt unplug rtm and try to unlock controller on its own.Pt confirmed they were able to unlock controller and both controller and ins were 100%.Pt then said the screen said "stimulation is off".Pss reviewed how to turn stim on using the top white on/off button and pt confirmed stim had turned on.Pt said they were on group a, but thought rep nicole was on group b when they set the pt up.Pss reviewed general group information and how to change groups if pt wished.Pss reviewed with pt that if they just wanted to turn stim on/off or change settings, they didn't need to use the rtm.Pt said they did not tell the pt that, so they have been trying to use the rtm to connect to access stim/settings (pt mentioned last night they sat with the paddle over their back for an hour).Pss also reviewed the pt may have some difficulty charging until they were fully healed as they were just implanted 10 days ago.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12353226
• MDR Text Key: 267655494
• Report Number: 3004209178-2021-12749
• 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
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Date Device Manufactured: 05/03/2021
• 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: 86 YR