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)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2019

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: 977d260, serial#: (b)(4), product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 13-may-2023, udi#: (b)(4) ; product id: 977d260, serial/lot #: (b)(4), ubd: 13-may-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a trial patient with a wireless external neurostimulator (wens).The rep reported that they were currently in the operating room for a trial procedure.The rep noted that she had already swapped out the wens.The rep reported that the lead went in fine, nothing unusual.The rep reported that the lead connectivity was out of range.The rep reported that 0-7 showed 40,000 ohms; 8-11 show 7,500 ¿ 11,000 ohms; 13-15 showed 40,000 ohms.The rep changed the reference electrode to 9 and the results were as follows: 8: 7360 ohms 10: 8910 ohms.The rep reported that the patient currently had general anesthesia and couldn¿t stimulate the patient for sensation.The rep reported that the physician had currently wiped the lead several times and continued to show the same impedance reading.Additional information received from a manufacturer representative (rep).It was reported that the leads wouldn't connect to the wens.A different wens was used with the same results.The leads were removed and replaced.The issue was reported to be resolved.The leads were expected to be returned for analysis.No further complications were reported.

Manufacturer Narrative

Continuation of concomitant medical devices: product id 977d260, serial# (b)(4) implanted: explanted: product type screening device product id 977d260, serial# (b)(4) implanted: explanted: product type screening device product id 977d260, serial# (b)(4).Product type screening device product id 97725, serial# (b)(4).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 a manufacturer¿s representative (rep).The rep reported that there wasn¿t high impedance, couldn¿t get the leads to connect to the wens.The rep reported that the leads were removed and 2 new trial leads were used.The rep reported that the new leads were good and there were no issues with the new leads.No further complications were reported.

• 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
• MDR Report Key: 9187485
• MDR Text Key: 173544921
• Report Number: 3007566237-2019-02123
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1