MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97725
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896); Connection Problem (2900); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a trial patient via manufacturer representative.It was reported that patient's stim stopped working and comes on and off intermittently.Wireless external neurostimulator (wens) also unable to communicate with patient controller and out of regulation (oor) being shown without allowing patient to turn device down.The cause was unknown.Troubleshooting involved changing battery in the patient controller.Impedances checked showing none but connection issue on contact 4.Tried re-seeding several times with no luck.Attempted to disconnect patient controller and re-connecting but continued to not allow patient to turn amplitude down.Wens was replaced after troubleshooting all options.After wens was replaced, able to adjust amplitude to patient¿s liking.Patient immediately reporting improved pain control.The issue was resolved.Hcp had no further information.Patient's weight was asked but unknown.The product was going to be returned.No symptoms were reported and no further complications were reported/anticipated.
Additional Manufacturer Narrative
Corrected device code c62952 to c63114.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.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 or Problem Description
Additional information was received from the rep.It was reported that the wens was sent back today and was resolved by replacing wens.
Additional Manufacturer Narrative
A correction was made to reflect most accurate conclusion code.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
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8231249
• Report Number: 3007566237-2019-00098
• Device Sequence Number: 11175863
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/09/2019; 04/23/2019; 07/29/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 01/16/2019; 04/23/2019; 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR