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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 Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problems Dehydration (1807); Fever (1858); Headache (1880); Pain (1994); Shock (2072); Tingling (2171); Distress (2329); Complaint, Ill-Defined (2331); Malaise (2359)
Event Date 02/18/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative and a patient who was implanted with a neurostimulator for spinal pain. It was reported that the patient went on a trip to (b)(6) around (b)(6) 2014 and took stim with them. They were hooked up to some sort of generator and ever since the patient has come back, they have had problems. The problems have been medical in nature and not related to the device. It was reported that either the device inside the patient or her handheld device was not working. The patient noticed that it stopped working on the (b)(6) 2016 in the middle of a very bad attack of irritable bowel syndrome. The patient had been really ill, in a lot of pain, stressed, dehydrated, fever, and "a lot of stuff. " the patient said that she normally has back pain and her migraine which is constant and never go away. The patient had just left her pain therapy health care provider office on (b)(6) 2016 and she thought that her body went into shock when the device stopped working. Even now she feels like a humming/vibration when she gets up and moves. She noticed it ever since she stopped being ill. She normally has constant tingling in her feet that has gotten worse and goes from one foot to the other foot. The patient reported that she was still kind of ill at the time of the report. Additional information was received from the manufacturer representative on 2016-08-30 that reported that there was an alleged overdischarge. A physician mode restart was started, but about 3-4 minutes into it, they saw a 375 error code on the recharger. The patient had seen this code about a month prior to the report. About 6 weeks prior to the report, the patient stated that the recharger cord was bending a lot and the wire was starting to come out of the insulation so they put electrical tape on it to hold it together. Communication could not be established with the patient programmer, implantable neurostimulator recharger, or the clinician programmer. Within in the last 6 months, the patient has had difficulty charging as they have a hard time getting 6-8 coupling bars. The patient is able to charge the implantable neurostimulator and then it depletes quickly. There was not a spare recharger, so the manufacturer representative was going to meet with the patient again when they got the replacement implantable neurostimulator recharger antenna so that they could continue the physician mode restart. The manufacturer representative was also going to do further troubleshooting with the difficulty recharging and the quick implantable neurostimulator depletion. The patient's medical history includes that the patient is disabled with chron's disease and parkinsons. She has chronic pain and goes to a monthly appointment so that she can get her medication. Her spinal cord stimulation helps with the walking and everything else helps so that she does not have to use her cane. The patient also has fibromyalgia.
 
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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 Key5946333
MDR Text Key101044152
Report Number3004209178-2016-18789
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2012
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 Received08/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2011
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: 09/13/2016 Patient Sequence Number: 1
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