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

Model Number 97715

Device Problem Data Problem (3196)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/09/2021

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 (pt) regarding an implantable neurostimulator (ins).The reason for call was pt stated within the last couple of weeks, 7/10 times when they check the stimulation levels in the morning the intensities of the programs would all be 0.Pt said the stimulation intensity would be normal (not 0) at night, but it would be in the morning that they would notice all 0.Pt said they kept a log of when they recharge, and when they noticed all 0, ins battery would still have some charge (pt did note that the ins battery would still deplete some when intensity was all 0).Pt then said they would try to turn intensity back up, but the stimulation/intensity usually wouldn't turn back up/on until it kicked back on itself (pt confirmed stimulation intensity would turn back on and not be 0 anymore on it's own).Pt had not noticed the issue happening in any certain position or activity.The circumstances that led to the reported issue were asked but unknown.Pt said intensity was all 0 this morning, but a couple hours after they woke up, stimulation kicked back on, so stimulation was working during the call.Pt was on group b, which is what they had been on.Pt went into program 1 and reported seeing icons for intensity, stimulation, and adaptive stim (all of which were on), but no other options.Pss asked, pt said they didn't have cycling programmed in.The issue was not resolved.The patient was redirected to their healthcare provider (hcp) to further address the issue.Pt mentioned their rep text them saying they were going to contact hcp to set up a time to meet with pt to check programming, but suggested pt call patient services first.Pt said the stimulator, since implanted, had helped their upper back, but never helped with their lower back or legs.Pt said they tried programming in the beginning, but could not get it to help lower back.Pt then said rep had pt try group b, and group b worked for the first couple days, but then stopped working for pt's lower back.Pt said their rep now wants to try hd programming to see if that would help.Pt mentioned they were going to meet with rep  again for programming to help with the pt's pain in lower back and down their left leg.The stimulator, since implanted, had helped their upper back, but never helped with their lower back or legs.Pt tried programming in the beginning, but could not get it to help lower back.Pt then said rep (b)(6) had pt try group b, and group b worked for the first couple days, but then stopped working for pt's lower back.Pt said their rep now wants to try hd programming to see if that would help.

Event Description

Additional information was received from the manufacturer representative (rep).The cause of stim intensity going to 0 issue was not determined.The issue was not resolved.The rep reprogrammed scs.Additionally it was reviewed that rep should check adaptive stim settings.

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 reported that the patient said the ins regularly resets the amplitude to 0.0.Factors related to this are unknown.On last visit interrogation looked normal.Patient reset amplitude values back to suggested for dtm.The issue was not resolved at the time of the report.

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: 11722877
• MDR Text Key: 247320279
• Report Number: 3004209178-2021-06625
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR