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

Model Number 97715

Device Problems Degraded (1153); High impedance (1291); Connection Problem (2900); Positioning Problem (3009)

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

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable component: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer's representative and a healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's ins was replaced on (b)(6) 2019 and there was difficulty removing the lead inserted into the old ins for the 0-7 contacts.After some effort, the lead was successfully removed and it appeared discolored.The lead was inserted into the new ins for contacts 0-7.It was difficult for the healthcare provider to smoothly insert the lead into the port but with more effort the lead was successfully inserted and connection on the clinician tablet showed an unsuccessful connection with contacts 0-7 and a successful connection with contacts 8-15.Impedances were out of range for contacts 0-7 and were displayed as being greater than 40,000 ohms.The representative was able to successfully program the new ins for the patient and the patient had good bilateral low back and leg coverage.The representative noted that the 8-15 contacts showed a false positive with regards to its impedance values but it displayed the green check mark and indicated they were good to use.No further complications reported.

Manufacturer Narrative

Concomitant medical products: product id 39565-65 lot# serial# (b)(4) implanted: (b)(6) 2011 explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer's representative.The patient's device information was updated.No further complications reported.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 8359782
• MDR Text Key: 136864125
• Report Number: 3007566237-2019-00438
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR