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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 Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Patient Problems Pain (1994); Malaise (2359); Electric Shock (2554)
Event Date 04/01/2016
Event Type  malfunction  
Manufacturer Narrative
Additional information suggested the event began in april or may of 2016. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported the patient first noticed the shocking in (b)(6) of 2016. The patient was not feeling well and said they were having pain in their neck, arm, and back. It was the same pain that they got the device for. The patient wanted to increase voltage because they wanted to see how high the voltage could go that they could tolerate. The voltage went higher than 4. 2 volts, and that caused the patient to feel shocking and it made the patient jump out of their chair. The voltage was decreased which resolved the shocking at that time. The caller said that the device seems to shock the patient more when the ins charge gets low. The device is then charged back up and the patient doesn¿t feel shocking as often or as bad. The caller said on (b)(6) 2017 the shocking resolved on its own. The caller thought maybe it was the patient¿s nerves on (b)(6) the caller called a manufacturer¿s representative (rep) who told them to turn the device off and turn it back on. The shocking seemed to resolve after doing that. This information was contradicting to what the caller said as the caller said the patient still feels shocking once in a while; not always but sometimes. On (b)(6) 2017 the patient had an appointment with their healthcare provider (hcp) because the patient¿s neck was bothering/painful for them a lot. The patient did tell the hcp about the shocking they had been experiencing. The hcp had the patient get a cat scan. The hcp told them that everything looked fine; everything was in the correct place; nothing appeared to be wrong with his neck. No reprogramming was performed on (b)(6)2017. The patient has no plans to see the doctor for further troubleshooting to resolve the shocking. The caller mentioned that they know the device will likely need to be replaced in (b)(6) 2019 because it will be old at that time, but they confirmed that there is no planned/scheduled appointment for the replacement yet. The caller confirmed that the patient was in and out of the hospital for various reasons the last month, but the visits were not related in any way to the device or therapy. No further complications were reported.
 
Event Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for failed back surgery syndrome. It was reported that the patient had been experiencing shocking starting about 2 months prior to the report (confirmed as 2017). There was no fall or trauma related to the issue. The patient was redirected to follow-up with their health care provider. There were no further complications 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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7001231
MDR Text Key100288868
Report Number3004209178-2017-23149
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 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2011
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 Received01/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/28/2010
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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