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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37713
Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Interrogate (1332); Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problems Hearing Loss (1882); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Loss of consciousness (2418)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a manufacturer representative regarding a patient who was implanted with a neurostimulator for radicular pain syndrome (radiculopathies). It was reported on (b)(6) 2014 that the patient had communication problems between their recharger unit and their implantable neurostimulator (ins) and an overdischarge (od) condition was suspected on the ins. The primary reason for the overdischarge was due to patient compliance with the last successful recharge session was over 12 months ago. The patient stated that they had surgery over a year ago and turned the ins off at that time. They also stated that they had stopped using the device until recently. It was also mentioned by the patient that they had a stroke and had memory issues. Additional information was received on (b)(6) 2017 from a consumer and a manufacturer representative regarding the patient. It was reported that the patient was receiving stimulation without turning on the device and that the device stopped working long ago and they removed the device and the device randomly started stimulation. Additional information noted that the patient had turned off the device and it was found to be dead about 3-4 years prior to the report. As of (b)(6) 2015, a manufacturer representative was able to connect with the battery at the patient¿s home. Additionally it was reported that the last time that the patient had seen a manufacturer representative was at the hospital about 3-4 years prior to the report where her stimulation was turned off and her implantable neurostimulator was found to be dead. On the day of the report, the patient realized that the stimulation suddenly turned back on again and it was too high. Later, contradicting information noted that the change in stimulation was a gradual increase in stimulation sensation for about 3 days, starting on (b)(6) 2017. The patient thought that she was losing feelings in her legs because her back was so bad, but if she straightens out her spine, she could feel rhythmic sensations. It was reported that the patient had a bad fall where she lost hearing in her one ear and suffered from a loss of consciousness. This was noted as possibly being related to the issue. The patient was sick with lots of medications, narcotics, and hospitalized in the last few weeks. The device had been off for several years and the batteries had depleted per the manufacturer representative, but the device had now turned itself on and was on a high setting which hurts and is uncomfortable. It is not covering the intended area, and there was more sciatica. The patient had lost her patient programmer, so additional troubleshooting could not be performed at the time of the report. The patient met with a manufacturer representative on (b)(6) 2017, and it was determined that the patient was feeling stimulation. The manufacturer representative read the implantable neurostimulator using the clinician programmer and an overdischarge was confirmed on the implantable neurostimulator. The patient confirmed that she had not recharged for many years (since they met with the manufacturer representative last time). [all of the received information reasonably suggests that the device had not been removed in the past, as the patient had previously noted. ].
 
Event Description
Additional information was received from the manufacturer representative (rep). It was reported that the rep met with the patient to interrogate the battery but was unable to communicate with it. The cause of sudden start of stim despite patient's device being in overdischarge and stimulation not covering the intended area, the loss of hearing in one ear, sickness, pain, and discomfort was unknown. Patient was to make an appointment with a neurosurgeon to have the battery removed.
 
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 manufacturer representative that it was unknown if the device was going to be returned for any analysis as sometimes the physician will not inform the rep when battery removals are and do not require rep to be there. It was unknown what was patient's weight at the time of the event.
 
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Brand NameRESTORE ADVANCED
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 Key6397109
MDR Text Key102488677
Report Number3004209178-2017-05459
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,Followup,Followup,Followup
Report Date 03/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2009
Device Model Number37713
Device Catalogue Number37713
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 Received03/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/19/2007
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: 03/10/2017 Patient Sequence Number: 1
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