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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Cellulitis (1768); Coagulation Disorder (1779); Fever (1858); Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Ulcer (2274); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415); Skin Inflammation (2443); Burn, Thermal (2530)
Event Date 01/01/2015
Event Type  Injury  
Event Description
Information was received from a patient who was implanted with a neurostimulator for post lumbar laminectomy syndrome. It was reported that there was discomfort while charging as the implantable neurostimulator was too hot. There were a lot of heat problems from charging the device. The implantable neurostimulator/implantable neurostimulator pocket gets really hot during recharging. The patient reported that it burns her, and that she can only charge it half way because it burns her. The implantable neurostimulator battery inside her is hot all the time and the patient stated, it feels like you have a fever all the time. The patient wakes up in the morning with a great big blister. The burning sensation goes away when the stimulation is turned off. The patient has ulcers on her buttock and hip area, loses feeling her fractured foot and developed cellulitis in her feet from the stimulation heat and the caller was in the hospital not too long ago. The stimulation possibly caused nerve damage in the patient's foot/leg. The patient's foot has been operated on many times and the toenails have been taken off. The stimulation was currently at 1. 65 volts and it was driving her crazy. The stimulator has been a life saver and does help with her pain. As intervention, the manufacturer representative advised the patient to turn stimulation down and only charge it half way or recharge every 30 minutes. The patient reported that she was having an mri for other medical issues described as blood not clotting and bruising all over and a fractured foot. The patient reported that nobody told her before she was implanted that she could only have an mri of the head. The exact date that these issues started occurring is unknown, but the patient knows that they started sometime after 2015.
 
Manufacturer Narrative
Corrected information: sex, date of birth.
 
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Brand NameRESTORE ULTRA
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 Key5650475
MDR Text Key45033169
Report Number3004209178-2016-09373
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 05/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2011
Device Model Number37712
Device Catalogue Number37712
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 Received04/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/23/2010
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: 05/12/2016 Patient Sequence Number: 1
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