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); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Charging Problem (2892); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).Information was reported that the patient stated ever since she had the implant the stimulation has always been in the right position, and now since the implant the stimulation has been in the wrong spot.The patient stated all the stimulation is down the front and the patient met with a manufacturer representative (rep) yesterday at pre-op and they did an x-ray to make sure nothing moved however the rep could not get the stimulation to the back and switched to high frequency.The patient stated she wants the stimulation set back to where it was before she met with the rep.The patient stated she gets no relief from this and also stated her device is dead now as it's been on this whole time.The patient had a replacement (b)(6), and it was programmed however since covid the patient could not get an appointment until yesterday which was the preop appointment.The patient stated the stimulation is her legs and wants it in their spine.The patient stated the rep said it should be programmed as it was before the surgery.Up until yesterday she was feeling stimulation, but in the wrong spot.The patient stated if she turns a little she can feel a little bit.The patient stated he had to take 800mg of ibuprofen just to fall asleep last night.The patient stated she has the same lead in and only did the ins.The patient stated something had to have happened in surgery as something is off with the stimulation sensation.The patient mentioned she also has to charge daily since yesterday when she used to charge once per week.No further complications were reported.No additional patient symptoms were reported.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the stimulation was back to normal and the patient was having no issues.No patient complications were reported as a result of this event.

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.

Event Description

Additional information was received from the patient on 2020-oct-09.It was reported that the patient did not like the new settings as they were not helping.The patient noted that stimulation was wrong.She received over the phone support and was talked through changing settings back to the old setting.Now it's find and the patient is getting the stimulation needed for pain relief.The issue of the stimulation being in the wrong location has been resolved.The patient had to tweak the new settings, but they were able to do it themselves with over-the-phone support from a manufacturer rep resentative.

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 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: 10316188
• MDR Text Key: 207147583
• Report Number: 3004209178-2020-12730
• 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,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 49