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

Model Number 97715

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problem Electric Shock (2554)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient¿would like to get in contact with a mdt rep for programming concerns because their stimulation settings keep changing randomly by itself.Pt stated that they normally keep their settings on group c at.02 and since sometime around (b)(6) 2020, their stimulation settings have been increasing/changing by itself to 1.3-1.4.Pt mentioned that they noticed that they feel "zapping in their foot" while they are sitting on the couch, outside, sitting in a car in a straight up position, or walking on the treadmill.Patient services (ps) walked pt through checking to see if adaptive stim was turned on.Pt confirmed that adaptive stim was turned on and turned it off at that time.Pt then confirmed that they no longer feel increased stimulation while sitting on the couch.Pt stated that they recently lost 42 pounds and was concerned that may have somehow impacted their internal equipment.Pt stated that they attempted to call their physician's office and was given contact information of an mdt rep (first/last name asked/unknown) and left the rep a voicemail but has not been able to get in contact with them.Pt noted that they no longer see dr.(b)(6).Pt also mentioned several times that they really like the device, but they just want to meet with a rep for a check up to ensure that all equipment if functioning properly.Ps instructed pt to monitor the issue going forward and to contact their hcp if need be.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received.Patient reported setting got changed due to stimulator shutting down.Patient reported they were able to get settings back to manually.Patient has appt with hcp to check stimulator.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11706107
• MDR Text Key: 246693421
• Report Number: 3004209178-2021-06463
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR