MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Energy Output Problem (1431); Improper Device Output (2953)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)

Event Date 02/09/2018

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 consumer with an implantable neurostimulator (ins) for unknown indication.It was reported the patient stopped using therapy about 4 years ago and stimulation has turned on by itself and he can't turn it off.The patient said it isn't strong, but he doesn't want it on.The patient left his external equipment when he moved, and his family couldn't find it at his previous house when he checked with them.It was explained that it was unlikely that stimulation turned on by itself after not being used for 4 years, however the patient insisted he felt stimulation.The patient was redirected to their healthcare provider.No further complications were reported/anticipated.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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 Description

Additional information was received from the health care professional (hcp).It was reported that patient called stating the device came on not sure the cause.(b)(6) 2018 hcp offered patient an appointment but he did not have the money.Emailed rep for company.(b)(6) patient was told it was very important to be seen.Gave appointment and rep will be here to discuss with patient.(b)(6) patient cancelled appointment stating the stimulator was off.(b)(6) 2018 strong for patient.(b)(6) 2018 patient informed us still coming and going off not giving him pain when he can get in the office will call.No further patient symptoms or complications were reported in this event.

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

The patient said he noticed about 4 years ago his stimulator, which he has not charged or used in 5 years, he does not use it anymore, has a problem with it.What is going on is it is coming on when it wants to and going off when it wants to.Patient said, it is on right now but he does not need it on there is something wrong with it shouldn't be coming on it has not been charged in years.Patient said he needs it turned off because it is getting on nerves, all he needs to do is turn it off.Recommended patient have his system checked in person by his healthcare provider.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7419586
• MDR Text Key: 105376191
• Report Number: 3004209178-2018-07740
• Device Sequence Number: 1
• Product Code: LGW
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

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: 07/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 11/06/2020
• Supplement Dates FDA Received: 08/17/2018; 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR