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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586)

Patient Problem Sleep Dysfunction (2517)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that on (b)(6) 2021, they were woken up in the morning because they felt their stimulation shut off, however, when the patient checked their controller it showed the implanted neurostimulator (ins) was charged to 60% and it did not indicate the stimulation was off. the patient then turned the stimulation back on, but 10 minutes later, they felt the loss of stimulation again. they turned it back on again. this continued for 45 minutes, and then they decided to charge the ins.Once the controller showed 100% on the screen, it took another hour to indicate charging was finished.  the patient confirmed that the loss of stimulation they were experiencing had occurred when they were laying down and when they were sitting up, and they did not have adaptivestim active. the only thing the patient could recall that may have contributed to this event was a fall they had when getting out of the shower a few days prior to the report.The patient was redirected to see their doctor to have the ins checked.

Event Description

Additional information was received from the patient.It was reported the patient clarified that when the controller said stimulation was still "on" when they stopped feeling stimulation, they turned stimulation back on to feel stimulation again.The patient reports they have not seen the healthcare provider (hcp) yet.The hcp sent them for x-rays and they are still waitingto hear back from the hcp office.The repeated loss of stimulation and charging the ins from 100% charged screen to the finished screen continued to take an hour to complete has not been resolved, they had x-rays done and are waiting to hear back from the hcp office.

Manufacturer Narrative

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.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12122009
• MDR Text Key: 260299886
• Report Number: 3004209178-2021-10414
• 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: 07/28/2021

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: 10/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 91