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

Model Number 97715

Device Problems Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Muscle Weakness (1967); Scar Tissue (2060)

Event Date 08/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient reported that on (b)(6) 2021, they noticed their stimulation was "way off" as it was in new places.  they stated the stimulation was "now in their legs and should be in their neck".   the stimulation in their legs was making them weak in their feet when they tried groups a, b and c, so couldn't use a new group.  the patient stated they "may have over extended themselves when doing yard work".  they were redirected to see their doctor to further address the issue.

Event Description

Additional information from the patient indicated that the cause was not clarified, but the physician indicated that the stimulator is not in a high enough location.They noted that the manufacturing representative (rep) did some reprogramming.The patient stated that they will see the hcp again soon to determine if they want to add an adjustment to the wires to get it to where it should be at c5.They noted that scar tissue stopped placement at t1.The issue remains unresolved.

Manufacturer Narrative

Concomitant medical products: product id 977a260, lot#/serial# (b)(6), implanted: (b)(6) 2021,product type lead product id 977a260, lot#/serial# (b)(6), implanted: (b)(6) 2021, product type lead 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.

• 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: 12356085
• MDR Text Key: 267750408
• Report Number: 3004209178-2021-12784
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 45 YR
• Patient Weight: 94