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); Overheating of Device (1437); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: neu_recharger_acc, serial/lot #: unknown, ubd: , udi#: product type recharger 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 multiple sources (manufacturer representative, healthcare provider[hcp]) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was experiencing problems with charging, and was seen by the hcp on (b)(6) 2024.The ins was placed deeper.This caused the patient some discomfort, but the hcp was able to get a connection easily at the outpatient clinic.The patient received a message "software problem cannot continue.Please call medtronic. 1- intellis, 2 - 3.0, 3 - 243, 4 - qf_port".They regularly removed the battery pack for a short time, but this had no effect.The black part of the recharger antenna head cable sometimes got warm, but not always.According to the patient, the antenna would lose connection.In the outpatient clinic, the patient took different body positions such as sitting/standing, but this did not cause any connection issues.The controller also showed the recharge session had been completed even though the ins was not fully charged yet.The patient was 100% sure that they did not press the button on the controller.The patient had been struggling with this for a while now.The hcp thought the lack of patience also played a role for the patient.The hcp replaced the recharger antenna and battery pack, as well as printed out a session report and data report which were provided to the manufacturer.The session report and data report showed that in almost all charging sessions there was an average of excellent connection b etween the recharger and ins.In addition, it was seen that the ins was almost fully charged during most charging sessions, between 90-100%.

Event Description

Additional information was received from the manufacturer representative.It was reported that the issues first began about three weeks prior to (b)(6) 2024.It was noted that the recharger was the older design.The serial numbers of the recharger and patient controller were unknown, and it was unknown if the products were available or had been discarded.It was noted that this information was confirmed with the physician/account.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: unknown, product type recharger 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18982394
• MDR Text Key: 338996850
• Report Number: 3004209178-2024-07867
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• 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: 03/22/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/10/2024
• Date Device Manufactured: 09/09/2020
• 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