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

Model Number 97715

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Hypersensitivity/Allergic reaction (1907); Seroma (2069); Burning Sensation (2146); Electric Shock (2554); Swelling/ Edema (4577)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id neu unknown lead, lot# unknown , product type lead.Section d information references the main component of the system.Other relevant device(s) are: product id: neu unknown lead, serial/lot #: unknown.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 the health care provider via the manufacturer representative (rep) regarding a patient with an implant able neurostimulator (ins).It was reported that there were high impedances of 40,000 ohms with the 0-7 lead.The patient experienced shocking sensation when the stimulation was on, suggesting a fluid short, solved by reprogramming stimulation.The implant pocket was swollen, suspected allergic reaction.An allergy test has been requested.Additional information was received reporting the cause of the high impedances was not known yet.The cause of the shocking was also not yet known, but the patient reported that the sensation of shock was worse when the ins was turned on and when the intensity of the stimulation current increased, and also during the charging phase.When the ins was turned off, however, still reports a strong burning sensation in her pocket.The pocket was swollen on physical examination and with seroma.The patient had an allergy test, and the doctor was waiting for the results.Based on the results of the allergy tests, doctors will take the actions to resolve.

Manufacturer Narrative

Continuation of d10: product id 977a275, product type lead.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 from the rep reporting that no causes were identified.The allergy test was negative for contact allergy.At the moment the doctor has prescribed a local anesthetic patch to reduce the pain in the pocket, then would like to carry out tests for the materials that have not been tested because they were not available in the hospital tests (for example platinium iridium).Also required further diagnostic investigation of the pocket to see if any fluid had formed.The patient was well but continued to experience shocks in the pocket when the ins was turned on and burning sensation when it charges.If the patient turns off the ins, he no longer has these sensations but the burning sensation in his pocket remains.At the moment the oor impedances are the same on first lead #1,3,4,5,6.It was unknown if the high impedances were with lead lot number va2gnl3012 or va2gnl3011; follow up is being performed to get clarification.The doctor asks if we have specific tests for allergies to the implanted components.

• 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: 19213172
• MDR Text Key: 341663537
• Report Number: 3004209178-2024-10002
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Date Device Manufactured: 01/21/2022
• 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...."; SEE H11