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

Model Number 97715

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem Pain (1994)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient.Product id: 97755, serial#: (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer rep regarding a patient with an implantable neurostimulator (ins).The rep reported the patient stated that the controller was causing problems, it will suddenly go out of whack, what he has it set on shoots as high as it can go and sends the pain into his brain.It was reported that the patient clarified that they were not having a shock and didn't mean a shock.It was reported that when the patient is trying to recharge the ins, the controller shuts down, it disconnects often, if he moves a little bit it disconnects, also it is not charging fast, and the controller screen goes dark and the green light stops blinking.The rep thinks the wire has a short in it and needs to be replaced.It was reported that the recharger cord was frayed.The patient reported that while trying to recharge the ins, the controller screen went white and started "screaming at him".The patient took the battery out to get it to stop but when he put the battery back in, it did it again and he had to take it out twice.It was reported that the patient had stopped using stim for a period starting in january.The rep reported that the patient needs to have constant pain coverage for failed spinal surgery, they know it (stimulation therapy) works.They turned stim off in january and more recently turned it back on.

Manufacturer Narrative

Concomitant medical products: product id 97745 serial# (b)(6) product type programmer, patient product id 97755 serial# (b)(6) product type recharger.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 from the patient reported they were they were just sitting still in a recliner while charging battery implant and did not move.The patient reported that he contacted the rep and the rep direct them to contact patient services.The patient reported that the issue was resolved when the repair department sent a new controller and antenna.

• 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: 10309495
• MDR Text Key: 199932803
• Report Number: 3004209178-2020-12637
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 102