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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580)
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 (pt) regarding an implantable neurostimulator (ins).The reason for call was starting a couple years ago the pt would not turn their stimulation on when they are laying down for it "barbeques" them; pt stated that their implant zaps them.Pt stated that they're fine when walking around while the stimulation is turned on.Pt thinks that their implant battery needs to be replaced and about a year and a half ago the pt tried to get referrals from their hcp about their implant.The patient was redirected to their healthcare provider to further address the issue.The patient further reported that it takes them 5 hours to charge their implant and they have to charge their implant every 2 or 4 days for their implant depletes a lot quicker now (pt stated that they only had to recharge their implant every 10 days when they first were implanted).Caller was redirected to the healthcare provider (hcp).
 
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.It was reported their device no longer held a charge.The battery was not working and the patient could barely walk.
 
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 a consumer, the caller said it still was not working and realized the recharger antenna cord was loose which could be why the implant was not getting a good charge.They were not getting a stable connection when charging.They mentioned the screw was loose and "they don't trust it".A replacement recharger (insr) antenna was sent out.
 
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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 Key11415006
MDR Text Key234751704
Report Number3004209178-2021-03694
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00613994842343
UDI-Public00613994842343
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
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2013
Device Model Number37712
Device Catalogue Number37712
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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