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

Model Number 97725

Device Problems Low impedance (2285); Device Contamination with Chemical or Other Material (2944)

Patient Problems Fatigue (1849); Urinary Tract Infection (2120); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Information was received from a trial patient via manufacturer representative (rep) who was using an external neurostimulator (ens) for unknown indications for use.On june 6, 2023 the rep, covered a buried lead trial with the hcp.The hcp did a laminectomy at t8 and placed the paddle covering the t7/8 vertebral levels.She anchored the paddle and wanted 40 cm extensions to tunnel to the flank, where she would then proceed with the buried lead trial and connect the wens to the extensions.She had to ask the sales rep, for 40 cm extensions but he only had 20 cm on hand.This created an issue where there was not enough extension to be far away from the sterile opening.(b)(6) had asked the resident to pull the extensions out as far as i can leave in about, 4 inches of extension exposed to connect to the wens.In order to keep the area sterile, they did not put the wens in a boot but instead placed the wens in the area where the extensions were coming out under one large tegaderm.The patient continued to bleed from the site where the extensions were coming out and this bleeding then got into the wens. this occurred sometime tuesday into wednesday where the rep got the call wednesday night that i have to see the patient thursday to exchange the wens.As the rep headed down to the clinic.It was evident that the device operated as intended and shorted due to a large amount of blood saturated in the wens where the leads plug in.The hcp wanted to connect another 40 cm extension to the existing 20 cm extension, to give us further distance from the sterile site.The rep handed her the 40 cm extensions as well as the new wens.The hcp connected this and on the rep's tablet it showed no issue with impedances and connectivity was good.The hcp then dressed the area with sterile dressings once again.They then programed the new wens and the patient was satisfied.When the rep called the patient the next day on friday to see how they were doing, this is when the patient expressed that they were so exhausted that they sat down on their driveway thursday night.Neighbors had to help the patient get lifted onto her wheelchair, and when they did that, they had ripped off all of the sterile dressings from where the extensions come out to where they hook up to the wens.The rep got the hcp and her nurse on the phone with the patient so we were on a four-way call.They wanted to do this due to the high risk of infection, and to involve the medical professionals right away.They had asked for the patient to send them a photo of the leads before they put on new dressings, and afterwards to confirm they did in fact, put on new dressings.They had been advised if they did not feel confident in doing this to go to an er to have someone help with this.It was also discussed what to look for with signs of infection.The following day on saturday the rep had called the patient and she said they never ended up putting dressings on.The daughter had just come in the door and i had asked if i could speak to her.She confirmed that the extensions were completely exposed.The next day i had called the patient and she said she was getting 5% relief and could sit longer in a chair then before the trial.Monday, the husband called panicked that his wife was not as responsive as usual, and had been in bed all day.He felt he should call an ambulance.The rep told him to hang up with me immediately and call 911.Which he did.The rep communicated this to the hcp, and they had like the er know she was coming in.They ran tests upon her arrival and she had a urinary tract infection.The hcp then informed me monday night that they will plan to explant the paddle and extensions and not proceed with him implant.On tuesday morning, i was at the explant case.Once we flipped the pt on her stomach, we discovered that all the dressings were off once again.They had asked the hcp if she feels it was infected upon opening the incisions and she said she felt it was too early for an infection to start.She did not culture the extension site or the midline incision that had the paddle, however, she did note that it was starting to have a cloudy consistency in those incisional areas.She stated it was not pus and she did not believe it was infected.She proceeded to fill four liquid or containers of sterile antibiotic wash when flushing the incisions.She then closed the incisions and the patient has no further complications to my knowledge.The wens was discarded.The issue appeared to be resolved.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17152931
• MDR Text Key: 317463667
• Report Number: 2182207-2023-01183
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000278762
• UDI-Public: 00763000278762
• Combination Product (y/n): N
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2023
• Date Device Manufactured: 07/21/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female