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

Model Number 97715

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that when patient is hot and working outside he feels a shocking sensation down the arm.No falls or trauma reported or known.Per caller this has been occurring for the past few weeks.Patient implanted for cervical pain.We discussed seeing if shocking occurs when stim is off as one troubleshooting step.Caller believes can follow-up w/ patient at some point to troubleshoot further.

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

Pt stated they've been complaining for about a year now the spinal cord stimulation (scs) causing them to get shocked when they become overheated and/or overexerted from physical activity.Pt explained they get an actual shocking sensation into their shoulder and right arm when this occurs.Pt said they have learned they can stop the shocking by initially turning the neurostimulator off but then they discovered they could turn therapy off in only sub-group 1 under group b to cease sensation.Pt claimed x-rays done ordered by hcp last month show the leads had not moved but if they turn their head the slightest one way or other when overheated or overexerted it causes the shock.Pt indicated both he and his wife are career travelers full time so they are not often in houston.Pt indicated they had met with a rep in chattanooga, tn who made some programmed therapy adjustments but they are still having the same issues.Pt described another rep who set up ins programming initially, as blowing them off and being non-responsive also since they've been back in texas for a little over a month now.Pt stated they no longer want to deal with her while requesting communication with a different rep who will actually help them out.Pt claims their implanting physician referred them back to manufacturer because he doesn't really get involved in the mechanical parts of the scs system.Pt remarked at this point if there were any other option th ey would go with a different company but since it's the equipment installed inside their body they have no other option.

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14753932
• MDR Text Key: 302658328
• Report Number: 3004209178-2022-07896
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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: 12/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/26/2023
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male