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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 Device Operates Differently Than Expected (2913)
Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Numbness (2415)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
 
Event Description
Additional information was received from the patient that reported that the patient was not sure of the circumstances that led to the loss of therapeutic effect from the stimulator and lower back/leg pain. In (b)(6) of 2016 it just wasn't helping as well. In (b)(6) of 2016, the health care provider took x-rays and found more deterioration at l4 and s1. It was also found that the device was never programmed right. The manufacturer representative reprogrammed the patient hoping that it would help and it did not. The patient also found out from the neurologist that after a nerve conductor tests that the patient may have more nerve damage in her legs especially in the left leg. The health care provider recommended for the patient to have the stimulation removed as he felt that the patient needed a mri of her lower spine. This was also confirmed by the patient's orthopaedic surgeon who needs a mri done before he can determine the best course of treatment to help with the patient's pain and loss of feeling and use of her left leg. The patient saw her neurosurgeon on (b)(6) 2016 and he agreed that it would be best to remove the device so that the patient could get the necessary mri to help with her treatment. The removal is scheduled for (b)(6) 2016. The patient got tremendous relief form the neurostim for 2. 5 years and she doesn't know the actual reason that it stopped helping.
 
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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
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5961853
MDR Text Key101882885
Report Number3004209178-2016-19208
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
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 Received08/29/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/08/2013
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: 09/19/2016 Patient Sequence Number: 1
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