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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Environmental Compatibility Problem (2929); Output Problem (3005); Insufficient Information (3190); Data Problem (3196)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688)
Event Date 01/01/2017
Event Type  Malfunction  
Manufacturer Narrative

Occupation: non-healthcare professional. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulator - nonmalignant pain/ failed back surgery syndrome. It was reported that the patient was having trouble with his stimulator. Caller stated patient was active/ working and his back was killing him, including when laying down so he ends up taking tylenol to help. Patient was set at 390 and turned it up, but it didn't seem to do any good. Caller noted the patient had trouble turning it up and that the setting would drop back down to a lower setting. Caller stated the patient waited 3 min while making the change. Caller stated the setting was 220, right leg. 95 and left leg. 50. Caller noted the same thing happened in the past. Patient was not available during the call; troubleshooting not possible. Patient redirected to healthcare provider. No further complications were reported/anticipated.

 
Manufacturer Narrative

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

 
Event Description

Additional information received from the patient reported that the had been wearing a heart monitor for their heart condition and that when the readings were all 'static. ' this occurred at around the same time that the patient experienced the previously reported issues with their back and the change in settings. The patient clarified that their settings were too low to feel adequate therapy but that after waiting 3 min for adaptive stimulation to 'learn' the new setting, the issue resolved. The patient had not known that they had to wait 3 minutes for longer for adaptive stimulation. No further complications were reported.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received from the patient. It was reported that a few weeks ago they wanted to put a heart monitor on the patient and when the heart monitor was on, all of a sudden, all of the stimulating numbers dropped. The patient took the heart monitor off and gave it back to them after 24 hours and all they had was static on that. The patient said they didn't think it had anything to do with the stimulator, however, they had it at least 4 years and nothing had happened before. The patient stated it went from 4. 90 on the middle of their back down to. 05. The patient said it also works on each leg so they "are using 3 things on it". The patient said they went down to nothing or almost nothing and they had to finally set them back up again. The patient had to leave it for 3 something minutes but was told to try 4 or more minutes. The patient said it's working fine again and the heart monitor affected the stimulator. No further complications were reported.

 
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 the patient reporting that they wanted to know if being in high altitude could potentially cause their stimulator to use less battery. They stated that they were in the mountains for 10 days and usually charge their device every third day. They stated that they noticed the battery did not deplete much at all and so the charge was faster. They were wondering if being in high altitude could cause this. It was reviewed that high altitude shouldn¿t play a role and that the stimulator would still continue to run at the setting that they left it at. During the call the patient also mentioned this (b)(6) that they had a heart monitor and it turned their stimulation down causing them to have back pain. They stated they were worrying and just wanted to make sure their device was not going to do that again where their stimulation dropped down because it would give them back pain. The patient stated that their device had worked well for them. Patient services recommended that the patient continue to monitor if there are any changes since the patient just got home from the mountains yesterday evening. It was indicated that the issue of the stimulation dropping down due to the heart monitor began in (b)(6) of 2018 and it was asked but was unknown when the back pain began. No further complications were reported/anticipated.

 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7756461
MDR Text Key116897632
Report Number3004209178-2018-17527
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2015
Device MODEL Number37714
Device Catalogue Number37714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/06/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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