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

Model Number 97715

Device Problems High impedance (1291); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/16/2021

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) via manufacturer representative (rep) who was implanted with an implantable neurostimul ator (ins) for spinal pain.It was reported that the reason for call was pt said they had an unrelated medical procedure which was "needlepoint on a nerve" and had turned stimulation off beforehand.Pt said that when they went to turn stimulation on, they found they were getting a settings not available screen.Pt says this started "over the weekend.Pt says they normally use group c and it only has settings 3 and 4 available.Pt says on setting 3 at 2.9v its not helping her pain and if she tries to increase it they get settings not available and also get this screen on setting 4 if they try to go any higher than 3.8v.The patient took the battery pack out of controller and then put back in, but this didn't resolve issue.It was advised following up with healthcare provider (hcp).The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included pt says the needlepoint procedure they had is because of a "knot on my hip" and says they have had it done "like 3 times and this is the first time i see this settings not available screen".The rep will meet with the patient on (b)(6) 2021 to evaluate and reprogram the ins.

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 a manufacturer representative (rep).It was reported that the rep met up with the patient at dr.(b)(6) office.The patient was seeing unable to deliver desired settings on her controller.An impedance test indicated electrode 8 red and electrode 12 orange.Both of these electrodes were being utilized in her current programming.The rep reprogrammed for improved coverage avoiding those electrodes.The patient came in using group c which was causing some rib stimulation and she¿s currently using group b b3 0-1 pw 300 r 40 left buttocks and leg b4 1+6- pw 300 r 40.Right back and leg sensor was activated and adjusted.The patient was very happy with the results, with much improved coverage.She will call if she needs anything.

• 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: 11208548
• MDR Text Key: 243861299
• Report Number: 3004209178-2021-01133
• 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: 01/26/2021

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: 05/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR