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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 Unintended Collision (1429); Energy Output Problem (1431); Ambient Noise Problem (2877); Battery Problem (2885); Charging Problem (2892); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that since yesterday the therapy was not helping the patient¿s pain at the bottom of their feet, and when they increased the stimulation was too strong.The patient stated this issue just started yesterday.The patient stated that they had a fall a couple of weeks ago and had an ultrasound on (b)(6) 2020, and the implant area was hit.The patient caregiver asked how the ins functioned in their body.Patient services confirmed that the patient programmer showed the ins was on and they were on group a at 1.45v.It was indicated that the ins charge level was 3/4 full.Patient services reviewed the ins functionality.Information regarding falls/trauma potentially causing the device to shift or move, and change how therapy was helping was also reviewed with the caller.It was recommended that the patient consult with their healthcare provider (hcp) for next steps.The event occurred on (b)(6) 2020.Additional information was later received from the patient the same day reiterating the previously reported information.They then also stated that when they turned their stimulation off, they could still feel the stimulation and they wanted to know why.It was reviewed this could be residual stimulation and that they should follow-up with their healthcare provider (hcp).
 
Event Description
It was reported that spinal stimulator was not working.The caller indicated that he couldn't determine what the patient was describing.After technical services reviewed the possibility of a completely depleted battery the caller indicated that he thought that sounded like what the patient was trying to describe.
 
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
The patient's primary care physician called to determine next steps for the patient, who was stating that he can't charge his battery.It was unclear what the patient had tried since yesterday and today.The caller didn't believe the patient had a managing hcp.Technical services reviewed with caller that it may be best to get a manufacturer representative (rep) involved and if they are open to, have rep come to clinic to meet with patient to charge and interrogate system.The caller was redirected to have a rep paged.
 
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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 Key10715791
MDR Text Key213925655
Report Number3004209178-2020-18435
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,health professional
Type of Report Initial,Followup,Followup
Report Date 11/02/2020
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 Date08/28/2012
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received10/21/2020
Supplement Dates Manufacturer Received10/28/2020
10/29/2020
Supplement Dates FDA Received10/29/2020
11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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