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

Model Number 37714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Data Problem (3196); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain and failed back surgery syndrome.Information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call was caller reported the pt have been having back pain on their left side.Pt described the pain as feeling "in the bone" and not the muscle.Caller stated the stimulator was implanted to help pain in both of the pt's legs and their back.When asked about ways the stimulator may have been impacted, the caller stated the pt was crawling around looking for a deer.Caller stated the pt is able to stand and walk but the pain is much worse when laying down.The patient was redirected to their healthcare provider to further address the issue.Caller mentioned the pt will likely have a cat scan since they can't have an mri.The patient's relevant medical history included caller mentioned the reason the pt had the stimulator implanted was related to the 5 back surgeries and a car accident they had at the age of (b)(6).

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.Patient indicated device has been returned.Patient reported explanted (b)(6) 2021.

Event Description

Additional information from the patient indicated that the ins was shutting off and changing intensities.They think it was getting old.The patient noted that the physician decided to replace the battery.

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.

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.Reason for call was pt reported that for the last 6 months they have had quite a bit of back pain and had some things going on with their stimulator.Pt said that they noticed a couple of months ago that their intensity settings changed from 3.80 to.80 on their left leg while lying down and the pt said they never changed the setting and always kept the setting at 3.80.Pt also mentioned another time within the past 6 months that their intensity settings for the middle of their backchanged without them changing them too; pt said that they didn't have their patient programmer by them at the times this happened.Pss had pt look at patient programmer during the call (nmh039543n) and pt said that everything seemed to be working just fine and their settings were where they should be at.Pt said that about 6 months ago they had a heart monitor on them and their stimulation turned off without them turning it off and they were in a lot of pain.Pt said that their doctor told them that the heart monitor results just showed static.The patient was redirected to their healthcare provider to further address the issue.Pt said they have an upcoming appointment with their dr.(b)(6) on october 14th at 8:45 am.Pss emailed medtronic reps for visibility.Pt was hard to follow at points during the call as they were talking very fast.Pt called from different call back number (b)(6) and pt already has a different phone 2.Pt had somewhere to be and rushed off the call, so ps unable to confirm if the pt wanted this number updated on file.

• Brand Name: RESTORE SENSOR
• 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: 12535825
• MDR Text Key: 273437716
• Report Number: 3004209178-2021-14450
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2021
• Date Device Manufactured: 06/06/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female