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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Failure to Interrogate (1332); No Device Output (1435); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)
Event Date 01/01/2016
Event Type  malfunction  
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 consumer regarding a patient who was implanted with a neurostimulator for spinal pain. It was reported on (b)(4) 2017 that the device was not turning on. Additional information was received on (b)(4) 2017 from the consumer reporting that they were sick. Information indicated that the patient was waiting for their programmer device. Additional information was received from the consumer on (b)(6) 2017 reporting that a hospital may be needed. The patient was in a wheelchair and in a lot of pain. Additional information was received from the consumer on (b)(6) 2017 reporting that the device was not working properly before they lost the programmer. The patient felt like they may pass out. Additional information was received on (b)(6) 2017 from the consumer reporting that overstimulation and a loss of therapy. Per the manufacturer representative the patient stated their recharger was getting to hot on (b)(6) 2017. The patient stated that their left leg was amputated below the knee in (b)(6)2016. When the patient turned stimulation on in (b)(6) 2016 after the amputation, their left leg ¿flew off the bed¿ from stimulation. On the day of the call the patient switched from program a to program b. Program b felt more comfortable but they were not feeling stimulation in their right leg. The patient could not feel stimulation in their right leg with either program a or program b. The patient was feeling stimulation in their left leg but not in their right leg on (b)(6) 2017. The programmer was not connecting and therefore unable to increase stimulation during the call; however, by the end of the call this issue resolved and the patient was able to connect the patient programmer and increase stimulation. Additional information received from the consumer on (b)(6) 2017 reported that after the program change that day ((b)(6) 2017) the patient was getting shocked. This was a sudden change. During the call, the patient was helped to change back to program a at 0. 7v and the patient stated that they were not feeling the shocking sensation. No further complications were reported.
 
Manufacturer Narrative
Corrected information: sex, date of birth. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
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 Key6477669
MDR Text Key72446567
Report Number3004209178-2017-07963
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 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2015
Device Model Number37714
Device Catalogue Number37714
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 Received04/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/25/2014
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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