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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Operating System Becomes Nonfunctional (2996); Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient¿s controller has been freezing on and off for about a year, sometime in 2019.They will have to reset the controller to resolve the issue.In the past two to three weeks they have been having issues with the ins taking longer to charge.It will take over two hours to charge the ins and it is depleting faster than they expect and the stimulation would turn off.It would take 45 minutes to progress.The patient states they saw what they remember as no device found.The patient encountered system problem rm04 on (b)(6) 2020.The patient¿s husband stated there is no damage to the recharger or the controller.The pins looked straight.The patient explained that the ins moved over time and is now basically over their spine.The ins movement was noticed in 2020.It was uncomfortable for the patient to charge due to the ins being over their spine because they have to lean back and it hurts.The last time they met with their healthcare provider (hcp) they mentioned possibly moving the ins.The patient confirms turning the ins up from 3.7 to 4.0.It was reviewed that stimulation can affect charging and ins depletion.The patient confirmed the controller battery was 100% and they were charging with excellent connection.No further complications were reported or are anticipated.

Manufacturer Narrative

Continuation of d11: product id: 97755, serial# (b)(6), product type: recharger; product id: 97745, serial# (b)(6), product type: programmer, patient.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

The consumer reported that they weren¿t sure what steps were taken to resolve the implant moving and taking longer to charge.The patient stated the issue was not resolved and they would be seeing their doctor in november.

• 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: 10221313
• MDR Text Key: 197838616
• Report Number: 3004209178-2020-11441
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 93