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

Model Number 97715

Device Problems Break (1069); Battery Problem (2885); Patient Device Interaction Problem (4001)

Patient Problems Burning Sensation (2146); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 26-oct-2021, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 26-oct-2021, udi#: (b)(4). The following products are reported in a separate regulatory report. See report #3004209178-2021-06703. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 97715, serial#: (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient has two systems implanted, cervical and thoracic. The patient stated hat her cervical implant has always caused her issues, specifically burning in her throat. She also reports having 4 grand mal seizures post nuss procedure. They believe this was caused by a new medication initiated post-procedure. The cervical was done after her seizures which shows electrodes on both leads that appear to be fractured. The rep attached an image for reference. The cervical ins was dead at the time of the report. The rep was unsure if the cervical lead issue happened before or after seizures but imaging post-seizure did show what appeared to be fractured leads. The patient wanted to have the cervical system explanted so they are planning to do that. Surgery was scheduled for (b)(6) 2021. The issue was not resolved at the time of the report.

• 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
• MDR Report Key: 11731756
• MDR Text Key: 247498994
• Report Number: 3004209178-2021-06741
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/27/2021 Patient Sequence Number: 1