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); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated she usually charges once a week.Patient woke up and noticed the implanted neurostimulators battery was dead but stated it should not have been dead.Patient stated she has to charge it at least twice a week.Patient tried to increase stimulation and she is getting the settings not available message.Patient turned the stimulation down and tried to turn it back up but she is not able to increase the stimulation due to that message.Patient service specialist asked patient if she has tried to switch groups or change the program settings patient stated she only has 1 setting to choose from.Patient mentioned that sometimes she can tell when she gets up from the chair she gets a jolt sensation patient stated this started last week patient stated the jolt sensation is more intense when she stands up.Patient made an appt with her healthcare provider on (b)(6) 2024 @ 10: 45 am.Additional information was received; rep reported high impedances; 11,000 for electrode 3.All other electrodes within normal limits.Patient had a return of pain; increased pain with some jolting sensations.Rep was able to reprogram around the contact, got good paresthesia coverage.Patient is happy with new setting.Issue resolved.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name pisces-quad; product id 3888-33 (lot: j0428000v); 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: 18959618
• MDR Text Key: 338555988
• Report Number: 3004209178-2024-07634
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 08/14/2019
• 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: 46 YR
• Patient Sex: Female