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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Dizziness (2194); Dysphasia (2195); Loss of consciousness (2418); Shaking/Tremors (2515); Cognitive Changes (2551); Convulsion/Seizure (4406); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from a patient's representative regarding an implantable neurostimulator (ins). The reason for call was callers (pt's husband and pt) requested assistance to use the programmer (pp) and confirm they successfully turned stimulation off. Callers said, since about a month and a half ago, pt has been having trouble with dizziness, light headedness, shakiness, speech problems and memory issues and contacted hcp who told them it was unlikely but possible the stimulator could be causing this. Callers said: but it has never done it before, so hcp wanted them to turn off stimulation because it is the simplest way to find out is to turn the system off. Reviewed button uses and icon meaning information, caller confirmed seeing the icon with no lightning bolt and confirmed stim was currently turned off. Callers will monitor and pt has a telehealth visit with hcp on monday. During the call, callers also reported there was one time in the past probably about 3 years ago, when hcp tried to increase stimulation and the patient had a seizure, so now stimulation is set at 3. 5 and that¿s where he wants it. Called caller back to ask about seizure outcome. Caller said, when it happened hcp may have stimulation off. The seizure stopped within 20 minutes, but he immediately called 911 and she was transported to the hospital to be safe, they had the system off for a month, before turning it back on. Caller said maybe a half a year later it was turned back up to 3. 50. Caller said she had all the tests from cardiologist, and she had no problem with her heart, her primary said maybe could be caused from her stimulator. Callers will monitor and pt has a telehealth visit with hcp on monday.

 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, 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
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11227467
MDR Text Key229098476
Report Number3004209178-2021-01340
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
Report Date 03/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2014
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 Received03/19/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/17/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/25/2021 Patient Sequence Number: 1
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