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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had a loss of stimulation.It was found that electrodes 6, 11-14 had out of range impedances.A replacement surgery was done on (b)(6) 2024 to replace the leads and the new leads resolved the issue.It was noted that the old lead had black corrosion or blood on many contacts.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name specify surescan; product id 977c265 (serial: (b)(6)); product type: 0200-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.

• 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: 18990463
• MDR Text Key: 338782191
• Report Number: 3004209178-2024-08010
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 04/28/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 84 KG