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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain and post lumbar laminectomy syndrome.The reason for call was pt states his battery will not take a charge, pt states he sees the reposition antenna screen and this has been going for a month.Pss advised to try programmer and pt gets warning screen to charge.Pt gets the reposition antenna screen on the recharger screen.Pt states taking longer to charge the last couple of months and this last month not taking a charge at all.Pss reviewed battery is so low and needs to charge before goes into an overdischarge.Pt was seeing power on reset (por) while charging, pss walked through how to charge and pt was charging with 2 boxes shaded.Pss reviewed will eventually have to clear por message on remote.Pss advised to try and charge by turning dial, etc the troubleshooting steps that were taken on the call resolved the issue.No patient symptoms were reported.
 
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 was received from the patient reporting that the last time they talked with their healthcare provider (hcp) they told them to talked to the person ahead of their case (possibly their manufacturer representative (rep)).The patient repeated that it took them almost a day to charge their ins and that the charge only lasted 2 to 3 hours.It was discussed with the patient that the implant would probably need to be replaced.The patient stated that they would talk to their surgeon.The patient was now checking on the status.
 
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 was reported that for about a year the patient's charge duration increased from 3 or 4 hours to 12 hours and their charge frequency changed from every 2 or 3 days to their ins charge not lasting through the night.Patient said that their health care provider (hcp) is for pain and they have a difficult time sleeping without their ins.The patient noted to continue to see receive por.The patient also noted seeing elective removal indicator (eri).The patient was redirected to their healthcare provider to further address the issue.
 
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 the patient indicated that the ins has been taking longer and longer over the past couple years to charge.They stated it takes 10-12 hours to charge and lasts only 4-5 hours.They noted that they will hopefully have the device replaced, but the issue has not been resolved at this time.
 
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Brand Name
RESTORE SENSOR
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 Key11224323
MDR Text Key229475757
Report Number3004209178-2021-01319
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00613994610430
UDI-Public00613994610430
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/14/2013
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/21/2021
Initial Date FDA Received01/25/2021
Supplement Dates Manufacturer Received02/01/2021
03/23/2021
04/08/2021
Supplement Dates FDA Received02/02/2021
03/25/2021
04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
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