MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97725

Device Problems Break (1069); High impedance (1291); Difficult to Insert (1316); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Device Displays Incorrect Message (2591); Malposition of Device (2616); Material Deformation (2976); Positioning Problem (3009)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial#: (b)(4), product type: screening device.Product id: 977d260, serial#: (b)(4), product type: screening device.Product id: 97725, serial#: (b)(4), product type: external neurostimulator.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 14-mar-2022, udi#: (b)(4).Product id: 977d260, serial/lot #: (b)(4), ubd: 14-mar-2022, udi#: (b)(4).Analysis of the leads found no anomaly.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was undergoing a spinal cord stimulation trial.It was reported that with the first lead, they had a loss of resistance upon implant, the lateral portion looked fine and posterior.There was difficulty positioning the leads.They connected the first leads to the wireless external neurostimulator and had connection, the space was okay, but the patient was only feeling stimulation in their stomach and never in their legs where they needed it.The stimulation was more to one side, and the lead then looked anterior.They were seeing out of regulation messages at this point, but didn¿t do a full electrode impedance check.They physician had to enter the space at a steep angle, so there was a slight bend in the lead and they couldn¿t get the stylet to the lead tip, so they decided to use a second lead and go up a vertebral level.It was noted that the first lead was attempted in the wrong location and the lead got kinked.The second lead went in seamlessly and lateral showed it was in a good posterior location, but when they connected to the wireless external neurostimulator, everything was red x¿s, except for 2 contacts.They removed the lead, reseated it, wiped it off, and tried the lead in both the 0-7 and 8-15 ports, but everything was showing red x¿s and high impedances of greater than 40,000 ohms.The manufacturer representative confirmed that they had set up two leads on the lead select screen and knew that the empty slot would show red x¿s, but they were seeing all red x¿s on the slot that had the lead as well.The manufacturer representative tried to remove one lead from the lead select screen to see if this would resolve the issue, and it did not.The physician had removed the lead 10-15 times and tried pressing it in further with no resolve.The manufacturer representative confirmed that the leads were seated properly.The manufacturer representative gave the physician the option to leave the lead in to test later, but when the stylet was removed, the lead completely shifted.They had gone through two leads and two wireless external neurostimulators.They aborted the trial, and the physician would like to retrial the patient at a later date.There were no further complications reported.Refer to manufacturer report #: 3007566237-2018-01562.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7542778
• MDR Text Key: 109373682
• Report Number: 3007566237-2018-01563
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1