• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Pain (1994); Swelling (2091); Dizziness (2194); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Electric Shock (2554)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient lost their programmer and they were in a lot of pain. Patient said she has had this pain for probably 2 months and had x-ray done by health care professional (hcp) and will speak to the health care professional (hcp) regarding the findings. Patient said this pain is in their right groin going around to their back it's like wrapping around and they think it's been more than two months since it started. It's gotten really worse since then. Within this last month it made walking really difficult and driving too, getting in and out of the car and walking up and down the steps. Patient told to sync patient programmer. Patient programmer showed stim off. Patient said she fell backwards and became dizzy because of the stimulation strength of their stimulator was too high and does not remember when this was but told the health care professional (hcp) about it sometime this year (2018) and the patient thinks the stronger increase in the stimulation could have been the reason they fell backwards. Patient said that she had been looking for their patient programmer and they hurt their knee while looking for the controller under the bed. Patient said they saw the health care professional (hcp) and manufacturing representative (rep). Patient said that she turned stimulation off last night because it was too high and it felt like they were getting electrocuted so they turned it off. Patient was offered some assistance to turn stimulation back on with her implantable neuro stimulator recharger but patient said she needs to wait for the patient programmer to come in because "it needs to be adjusted first, patient cannot just turn it on with the recharger because patient thinks it is at 5 right now but they think it needs to be adjusted before it was turned on". Patient was encouraged to follow up with health care professional (hcp).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from consumer reporting that they had swollen ankles and was in pain. No further complications were reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from consumer reporting that they were in extreme pain and without their programmer. Patient was also unstable with walking and could not sleep at night due to the pain level being at ten. No further complications were reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7435924
MDR Text Key106160871
Report Number3004209178-2018-08167
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,Followup
Report Date 05/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2014
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 Received05/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-