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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 Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Appropriate Term/Code Not Available (3191); Data Problem (3196)
Patient Problems Fall (1848); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)
Event Date 06/01/2018
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 patient with an implantable neurostimulator (ins) for the treatment of lumbar radiculopathy, chronic low back pain, and spinal pain.The patient reported that their device seems to be malfunctioning.The patient reported that it ¿keeps quitting¿ and doesn¿t maintain a decent stimulation level.It was reported that the scs was not giving the patient pain relief and that the patient is in pain all the time.The patient reported that they had falls.The programmer showed that stimulation was on group a at 2.65v.It was confirmed that adaptive stimulation was enabled, and the patient had previously thought it was turned off.The patient changed to group c during the call and confirmed that stimulation was in the correct areas.It was also reported that the patient was having an intermittent burning pain at the ins site and that it wakes them up at night.No further complications are anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative (rep).It was reported that the ins not maintaining a decent stimulation level was due to the patient sleeping in a reclined position and the transition zone settings needed adjustment in the adaptive stimulation program.The extent to which the falls affected the system was unknown, but the rep noted that the patient had not mentioned any recent falls to them.The rep reprogrammed the patient and the patient reported to them that they had zero coverage on program c.The rep was able to recapture coverage and the issue was resolved.It was also reported that the burning sensation was resolved by the patient turning off the stimulation, then turning it back on.The patient reported that the burning sensation was not as bad and then just went away.No further complications are anticipated.
 
Event Description
Additional information was received from a manufacturer representative (rep).It was reported that at this time patient was asked to keep a log.The rep was notified log kept by patient includes the ins going to 0v, in addition now includes the ins is changing groups by itself.Caller indicated when meeting with patient last friday, the patient really wants a new ins.Caller asked about reimbursement which was discussed as unable to assist and should be worked out by 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.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 manufacturer representative (rep).It was reported that the rep met with the patient to discuss a replacement.She is 7 years into her 9 year battery.Impedance normal.She was complaining of her battery feeling like it shuts off every now and then when she changes positions.The rep told her that it can fluctuate positionally and told her the next time it happens to connect her controller and check the numbers to see if they remain the same of if they drop down to zero and then document it.As of now the rep reprogrammed her for a new group f and she still has her original group h she can run on which both give her stimulation in her back and legs.The healthcare provider (hcp) agreed to not replace at this time, but to revisit the issue if her controller numbers are actually dropping down to zero.No falls for the patient and no further information at this time.Patient will reach out if the problem continues.
 
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.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.
 
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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 Key7723706
MDR Text Key115689972
Report Number3004209178-2018-16741
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 company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2013
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight89
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