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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); Therapy Delivered to Incorrect Body Area (1508); Vibration (1674); Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331); Reaction (2414); Sleep Dysfunction (2517); Cognitive Changes (2551); Constipation (3274)
Event Date 08/01/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for rsd/causalgia-complex regional pain syndrome. It was reported that the patient had a constipation issue, was not sleeping well, was not taking his medication on time, and would hardly eat. The caller noted that when the patient would eat the food would go straight through him. She stated that because he would hardly eat he seemed delirious. The caller reported that the patient took heavy opiates, hydro-morphine, fentanyl patches, psych drugs, and that he was on a lot of medication. It was noted that the patient had an outpatient surgery. The patient had an appointment set up with an hcp and a representative for (b)(6) 2017. The caller stated that patient was in between doctors and she was sent hcp listings. Additional information received from the patient's family member reported that nothing had changed in regards to her son not eating, having sleep issues and having constipation. The only guidance the patient has been provided in regards to their device is that they can turn it off. It was noted that the patient turns it off during bowel movements because it vibrates. They still do not have a managing physician or any appointments set up. Additional information was received from a friend/family member of the patient on 2017-jun-06. It was reported that patient had been having pain since before (b)(6) 2016. The patient reported that they were having a "reaction on their colon" and that they could see the implant vibrating in their back. The patient was having pain in their rectum and hemorrhoids when having bowel movements. It was reported that the patient had lost weight and was not eating well. It was reported that the patient was "in a stooper day and night" due to the hydromorphine, fentanyl patches, psych drugs, pain medications, and street drugs that they were taking. It was also reported that there was something wrong with the patient's implant and that it needed to be taken out. It was reported that the ins was checked by a couple of doctors and they said that the implant was not working correctly. The patient stated that the ins was "misfiring. " no further complications are anticipated.
 
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.
 
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
Additional information was received from the friend/family member of the patient. It was reported that they were unsure if the "reaction on their colon" was related to the device. It was reported that the patient just felt stimulation around the colon area a little heating when using the magnet. It was reported that the patient had an appointment with a new doctor on (b)(6) 2017. It was noted that the device was working fine at the time of the call. No further complications are anticipated.
 
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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
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 Key6656424
MDR Text Key101649987
Report Number3004209178-2017-13381
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,Followup
Report Date 07/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2011
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 Received06/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/07/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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