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); Impedance Problem (2950)

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

Event Date 02/23/2024

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the lead did not work/impedances did not work and the patient didn't have stimulation in the operation room when the patient had their ins replaced (b)(6) 2024).Connection impedance test didn't work.The patient had surgery to have the leads replaced on (b)(6) 2024.The leads were returned for analysis.Additional information was received from the manufacturer representative (rep) reporting that the connectivity test failed on both 0-7 and 8-15.They switched leads positions and both showed high impedances on all contacts.The treatment did not work.

Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6) ubd: 13-jan-2026, udi#: (b)(4), product id: 977a260, serial/lot #: (b)(6), ubd: 13-jan-2026, udi#: (b)(4).H3.Analysis of the lead 977a260 (b)(6) found that the stim lead body conductor was broken at the injex anchor site.Conductor #1, 2, 3, 4, and 7 were broken at 22.4 cm from the distal end.Analysis of the lead 977a260 (b)(6) found that the stim lead body conductor was broken at the injex anchor site.Conductors 0-7 were broken 20.2 cm from the distal end.H6.Conclusion code d16 no longer applies results code c21 no longer applies method code b21 no longer applies.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: 19000794
• MDR Text Key: 338886093
• Report Number: 3004209178-2024-08062
• 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,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 95 KG