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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 Run On AC/DC (1001); No Device Output (1435); Failure to Power Up (1476); Charging Problem (2892); Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359)
Event Date 08/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant products: product id: 37743, serial# (b)(4), product type: programmer, patient.
 
Event Description
The consumer reported that they had been very ill, their back had been very bad, and had been in bed for quite awhile off and on. The patient had been in the hospital twice in an ambulance for their back. It was reported that the patient's stimulator had not been working. They had been "out of it" due to bipolar issues and the patient was in chronic pain. There was report that the patient was not being treated for it. The patient reported that they were having issues with the patient programmer. They were not able to "power it up" and could not turn therapy on or adjust settings. It was reported that the patient was not able to troubleshoot alone and was having high bipolar issues. Recommended the patient to follow up with their healthcare professional (hcp). The patient did report that they would call their hcp but also noted that they do not have a hcp. Relevant medical history includes radiculopathy.
 
Event Description
Additional information received from the patient reported their previously reported issues had not been resolved. The patient stated that they were two hours away from home and didn¿t have their external device with them at the time of the call. It was reported that the patient was on a ¿bipolar high¿ so they were in a home. The patient mentioned that they were having issues mostly with their back, but also with their shoulder and neck. The patient reported that their neck was tweaking out because they needed to be in a quiet place and they weren¿t. It was also noted that the patient had laryngitis and was unable to get treated. It was unknown when the back, neck, and shoulder issues began.
 
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 received from the consumer indicated that the patient was in the hospital for a month because of bipolar issues and once they came back, they tried contacting their implanting physician but was told that they had not been in their office for 5 years and they would not see them anymore. All the information that was stored there was also destroyed.
 
Manufacturer Narrative
Concomitant medical products: product id 37743, serial# (b)(4), product type programmer, patient product id: (b)(6), serial# unknown, product type recharger. 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 received from the consumer indicated that the patient would look for a new doctor when they received physician listings. The recharger did not power up and did not recharge. The patient unplugged the recharger and then the recharger was on. The patient had not recharged since (b)(6) 2016.
 
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 consumer regarding the patient. It was reported that the patient was still having problems trying to get the device to power up. The patient stated she was going to seek assistance from her new healthcare professional to help resolve the issue. No further complications were reported.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6238894
MDR Text Key102630675
Report Number3004209178-2017-00568
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,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2009
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 Received03/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/18/2008
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: 01/10/2017 Patient Sequence Number: 1
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