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

Model Number 97725

Device Problems High impedance (1291); Connection Problem (2900); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Device available for evaluation: product id: 977a260, serial# (b)(4), product type: lead.Product id: 97725 ,serial# unknown, product type: external neurostimulator.Product id: 97725, serial# unknown, product type: external neurostimulator.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 22-oct-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the trial lead placement, the lead was placed in epidural space and connected to a wireless external neurostimulator (wens) but electrodes were not aligning into the wens.A manufacturer's representative (rep)continued to get error message that the electrodes not connected properly.The rep tried the lead in 0-7 part on wens then in 8-15 and the same electrodes were not connecting (red) on programmer.The rep used a new wens and the same electrodes continued to be out of alignment.Tried again in 0-7 <&> 8-15 in new wens.The rep then opened a new lead.The new lead and all electrodes were aligned and green.The rep was then able to finish the trial and program patient.The lead and wens were functioning properly.The issue was resolved.

Manufacturer Narrative

Concomitant medical products: product id 977a260, lot#/serial# unknown, product type lead product id 977a260, lot#/serial (b)(6),product type lead, product id 97725 lot#/serial (b)(6), product type external neurostimulator product id 97725, lot#/serial (b)(6), product type external neurostimulator.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 was received from the rep and it was reported that when the new lead was used the and the patient went to recovery 4 contacts were out.In recovery programming was fine except for 2 contacts.Lead pulled (b)(6) and all contacts were fine.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11007995
• MDR Text Key: 251544049
• Report Number: 2182207-2020-01482
• 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
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 73 YR