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

Model Number 97716

Device Problems Intermittent Continuity (1121); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

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

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that there were high impedances.There was a report of shocking, intermittent stimulation and pain at the ins site.The rep reprogrammed on 8-15 lead.New pain and pain at the ins were reported.  pt states pain at ins site and shocking sensations.Pt states no falls/slips/trips.Pt states issues first occurred about a month ago.Rep met with pt on 3/6/24 to reprogram device.Upon checking connections/impedance, 0-7 lead is showing high impedance issues and #14 showing 40,000 as an impedance value on 8-15 lead.And connection check is not showing green either.Unknown the cause of this issue.Troubleshooting was performed on 3/6/24 and a reprogramming was done using only 8-15 lead, avoiding #14.It is unknown if the issue was resolved.The manufacturer representative (rep) indicated they would send any further information as they become aware.

• 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: 19002697
• MDR Text Key: 338950942
• Report Number: 3004209178-2024-08088
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• UDI-Public: 00763000315474
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Date Device Manufactured: 05/28/2021
• 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 Sex: Female