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); Migration or Expulsion of Device (1395); Unstable (1667); Communication or Transmission Problem (2896)

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

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins).It was reported that the nurse contacted the manufacturer representative (rep) because one of their patients, who has had an intellis neurostimulator (97715) for 3 years, is experiencing connection problems between her remote control (97745) and her stimulator. when the patient activated her remote control to change program intensity, she was syst ematically blocked on screen 16: "no device found", which meant she had to connect her antenna (97755) to communicate with the stimulator.According to the center, the remote control and the antenna have already been changed, the pairing between the remote control and the stimulator has also been redone without success, and an x-ray was carried out and did not show a flipped ins.No symptoms were reported.Additional information was received from a manufacturer representative (rep).Regarding the cause of the no device found screen and communication issues, it was reported that the situation is not clear because the event was reported by the patient without the possibility to verify it.The patient will be seen again in consultation on october 25 in order to clarify the situation which seems to be resolved according to the information provided by the center by phone.So far as the rep knows, the decoupling and coupling the ins via the technician mode from the suggestion of technical services resolved the issue.Further actions to resolve the issue are that they will have a consultation on october 25th to investigate it.The provided information has been confirmed with the physician/account.Additional information was received from the manufacturer representative (rep) reporting that the ¿no device found¿ screen cause remained undetermined; it also happened while the ins was charged.Further actions taken was the nurse tried to resolve by re-pairing the ins with the patient controller but did not work.The issue did resolve by pairing the ins with a different patient controller.Additional information was received.It was reported that corrective maintenance and repair was needed.The customer communicated written or oral dissatisfaction with the product; defective.[reverse issue (20240103047)] additional information was received.It was reported that the patient describes that their controller does not detect their implanted neurostimulator (ins) even though it is fully charged.They explain that they must use their recharger to find the connection.This would have started a few weeks after implantation of the ins.The controller and recharger were replaced in october and seemed to have resolved the problem.The patient explained that this problem has returned since these replacements.The fault was not noticed by the follow-up nurse, and we were not able to reproduce it when they came.The interrogation does not allow us to find any environmental elements that could induce interference.Interrogating the ins with the physician tablet shows no alert but little use of the ins by the patient.It was proposed to let the patient write down the time/date of the events.When the patient comes back to the hospital it is advised to send us the session report, manufacturer report and diary of the patient.This way we can try to compare all the information.The current ins is therefore located a few centimeters lower on the abdominal area than the first one was.And this ins seems less parallel to the skin.Resolution of the issue is unknown, no patient harm reported.Additional information was received.The rep stated that they were only informed of this problem last october, but the patient declared that the problem occurred a few weeks/months after implantation, without giving a precise date.It was confirmed that the recharger had already been returned.It was confirmed that the ins was not depleted at the time the rep meet with the patient, but per the patient, the device shows little use of the ins by the patient.Impedances were normal.The depth of the ins seems correct, but the ins does sometimes tilt tangentially to the skin but would not be returned.As the center was not able to observe the problem directly, the patient was asked to note the times when the problem occurred (date/time/circumstance) and the center suggested that she come back as soon as this happened so that it could be resolved.Information confirmed with physician / account.

Manufacturer Narrative

Continuation of d10: product id 97755, serial# unknown, product type recharger product id 97745, serial# (b)(6), product type programmer, patient product id 97745, serial# unknown, product type programmer, patient g2.Foreign: france.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.It was confirmed that the ins cannot be repositioned, but it was stated that the ins is not mobile.The cause of the communication issue remains unknown, and the issue was never observed by the nurse, physician, or a manufacturer representative.The patient has not returned yet documenting if the issue has occurred again.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# unknown, product type recharger, product id 97745, lot# serial# (b)(6), product type programmer, patient product id 97745 lot# serial# unknown, product type programmer, patient 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.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19000993
• MDR Text Key: 339145935
• Report Number: 3004209178-2024-08061
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/10/2024
• Date Device Manufactured: 03/12/2020
• 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 Sex: Female