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

Model Number 97715

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

Information was received from a patient regarding an external device.  the reason for call was patient reported they were having issues charging their implant and the issue began a couple months ago.Patient stated they were 'having the devil' trying to find the right spot to get it to stay and it was driving them crazy.Patient noted they would move the paddle around and it would beep saying not right.During the call agent walked patient through removing the battery pack and plugging controller into the ac power supply cord; patient confirmed controller powered on.Patient inserted the battery pack and confirmed controller was 90% and implant said recharge.Patient confirmed the area where the wire connected to the paddle was loose and cracked.The issue was not resolved.No symptoms were reported.Patient called back and stated they received the replacement recharger and used it once or twice just fine, but last night when trying to charge the implant the controller went all white/unresponsive.Patient stated they couldn't get the controller to do anything and even tried taking the battery out.Patient said eventually they plugged the controller into the power supply and left it overnight.Patient said this morning when they looked at it, it said "software problem 1- intellis, 2- 3.6, 3- 58, 4- qf_new." agent walked patient through removing the battery pack and plugging controller into the ac power cord; confirmed controller powers on.Patient inserted the battery pack and confirmed controller is 60% and implant is 30%.Patientexamined the controller port and noticed the first most connection pin is darkened and really difficult to see.No symptoms were reported.Pt called back and repeated information from this case.Pt mentioned they received the replacement controller, but there wasn't a battery pack.Patient services (pss) reviewed they need to use their current battery pack into the replacement controller.Patient called back and stated they were about to throw their equipment in the yard because they're still having issues recharging the implant despite the replacement recharger and controller.Patient stated that the past couple days they have had to keep fighting it to keep charging and only get a little bit at a time.Patient stated they're finally up to 60% today, but they've had to stop and restart a bunch of times.Patient stated once they saw a message that said something like "code mc5" and then they saw a message about the controller batteries being low even though it was still at 60%.Patient examined all the equipment for damage and denied any visible damage.Pt called back stating that three times in the last six months, they had equipment replaced.Pt said that they got a recharger, a controller battery and then a whole new system.Pt said that the equipment hadn't been working good ever since.Pt said that they kept having issues so the equipment was replaced at different times.Pt said that the battery didn't fit in the controller; agent understood that the pt had the wrong controller battery compartment cover.Pt said however that the controller cover was raised and rounded.Pt said that the cover fit at the bottom but not the top as there was a little space like the battery was too big.Pt said that while recharging the ins, the controller kept coming up with system problem rm05.Pt said that they would reset the controller and then the equipment would work for a while, but almost every time when trying to charge the ins, the error message would appear.Pt said that they were having a hard time trying to find the ins when trying to recharge the ins.Pt said that they could feel the ins, but they were not feeling the ins near like they used to.Ptsaid that one time while there were in a clinic with a rep, they didn't have their equipment present, but the rep said that everything looked good on the inside.Pt said that they were currently recharging their ins and that recharging was flashing, but the ins was in the red and was empty.Pt noted that they didn't think they had ever seen the red triangle by the ins battery before.Pt said that terminated would be indicated when they hadn't even moved.Pt confirmed that the ac power supply green light was on.Agent had the pt remove the battery pack from the controller and connect the controller to the ac power supply; pt confirmed that the controller powered on.Agent then had the pt reinsert the battery pack into the controller while the controller was still connected to the ac power supply; pt confirmed seeing the controller light flashing green.Pt said that one of the little tabs on the controller cover was broken.After unlocking the controller, a battery empty message appeared.Pt noted that the controller was at 90%.Pt saw no apparent damage to the equipment.Agent had the pt clean the recharger connectors, clear the controller port of any possible debris, and then initiate an ins recharging session.Pt said that they used to be able to charge the ins through their paints, but it seemed like it was getting harder and harder.Pt said that they saw recharging good and then recharging excellent, but it kept going back to recharging good.Pt said that it seemed like the recharger didn't get a good connection to the ins anymore.Pt said that it was taking forever to recharge the ins.2023-sep-12 rpl 399846 (con): additional information was received from the patient.Pt called back and says they are still having trouble with controller and says it will go blank when charging ins and they still see an rm-05 code.Pt says that 1 pin looks different than the other pins in controller port.Emailed repair to send replacement controller.

Manufacturer Narrative

Continuation of d10: product id 97755-s lot# serial# (b)(6): product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755-s, serial/lot #: (b)(6) h3:analysis of the 97755 recharger (rtm) (serial number (b)(6)) revealed controller wont power on when rtm is plugged in.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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: 18810608
• MDR Text Key: 337630960
• Report Number: 3004209178-2024-06021
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/29/2024

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 Expiration Date: 01/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2018
• 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
• Treatment: "SEE H11...."