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

Model Number 97715

Device Problems High impedance (1291); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

(b)(6) 2023 information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported that they met with a manufacturer representative (rep) earlier last month because the stimulator 'stopped working.' patient said that the representative bypassed the issue and got the patient back online, but now the issue was happening again - pt was again seeing settings not available message.Pt mentioned being told sometimes scar tissue impedes the stimulation over time and wondered if they'd need the lead replaced.Patient service specialist reviewed role of representative and redirected patient to healthcare provider; agent provided national answering service (nas) number and explained use.The patient was redirected to their healthcare provider to further address the issue.Pt said they had been given contact information in the past, and the rep they were working with was usually very good.Pt mentioned the experience they were having with their new ins was worse than the old one.(b)(6) 2024 additional information was received from a manufacturer representative (rep).The rep reported that they reprogrammed the patient and they are getting good relief.There was an impedance issue with one of the leads.One or two electrodes were not firing.Rep reprogrammed around the issue and are currently getting good relief.(b)(6) 2024 additional information was received from a manufacturer representative (rep).The clarified the impedance issue/not firing issue.Rep looked up patient notes and said pt had impedance on 2 3 that were 40000.There was no specific cause identified for the impedances.

• 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: 19000182
• MDR Text Key: 339244006
• Report Number: 3004209178-2024-08069
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2023
• Date Device Manufactured: 10/27/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female