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

Model Number 97715

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2020

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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that patient is programmed with dtm on group a, b, and c.Caller reports patient felt good stimulation coverage on group a and c, and better coverage on b.Caller reports patient indicated the stimulation stopped working about 1 week or so ago.Reports he has been working with patient since than in switching to different groups over the phone.Reports switching to different groups helped, but than stopped working.Reports now all 3 groups stopped working caller reports no fall or trauma, but patient had ct scan about 1 week ago.Reports patient had ins turned off for the ct scan.Patient indicated no pulling or tugging felt on the ct scan.Caller reports impedance looks normal and lead connectivity looks normal, all green.Caller reports group a programmed: electrode 1/3 and 5/7 group b programmed: electrode 10/12 and 13/15 group c programmed: electrode 8/10 and 12/14 electrode impedance: reference 10 12: 480 ohms 13: 490 ohms 15: 490 ohms 8: 530 ohms 0-5: 700's ohms 6: 690 ohms reference 12 8: 510 ohms 14: 300 ohms 1: 670 ohms 3: 690 ohms 5: 690 ohms 7: 720 ohms reference 13 8: 510 ohms 9: 520 ohms 10: 490 ohms 11: 440 ohms 12: 410 ohms 14: 310 ohms 15: 430 ohms 0-7: 600's ohms 7: 720 ohms reprogramming using electrodes: 7/12: 450pw/42hz.Felt stimulation at 3.8ma 10/5: 450pw/42hz.Felt stimulation at 3.6ma 10/3: 450pw/42hz.Felt stimulation at 3.2/3.3ma 13/7: 450pw/42hz.Felt stimulation at 2.2ma.

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 received from manufacturer representative who responded back from follow up sent.Rep reported patient weight was unknown.Cause of loss of stimulation was unknown, tech services believed it was possibly a short not showing.Rep reported they re-programmed around it and stimulation was achieved, pain was good.

• 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
• MDR Report Key: 10843083
• MDR Text Key: 216575976
• Report Number: 3004209178-2020-20025
• 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
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR