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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 Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Malposition of Device (2616); Charging Problem (2892); Device Operates Differently Than Expected (2913)
Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 10/27/2010
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Main component of the system and other applicable components are: product id 39565-30, serial # (b)(4), implanted: (b)(6) 2010, product type lead; product id 39565-30, serial # (b)(4), implanted: (b)(6) 2010, product type lead; product id 3708140, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3708140, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 37743, serial # (b)(4), product type programmer, patient; product id 37752, serial # (b)(4), product type recharger.
 
Event Description
Patient reports while stimulation is turned on, the stimulation is occurring in the wrong location since implant. The patient cannot seem to get the stimulation to go up the middle of her spine where it is needed the most. Additional information was received from the patient on (b)(6) 2016 stating that the spinal cord stimulation (scs) device was removed because it never really worked. It was noted that the leads never went high enough. The complete scs system was removed at the end of august. The patient experienced thoracic pain and noted that they were miserable because they were in so much pain. They thought the doctor "really messed something up" when they were removing the device. They stated that the nerves on their right side were dead, so they put another stimulation system on the left side because they had no response on the right. The patient was crying and in a lot of pain. The indication for use was gastrointestinal / pelvic floor and lumbar radiculopathy.
 
Manufacturer Narrative
Other applicable components are: product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2015, product type: lead. Product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2015, product type: lead. Product id: 3708140, serial# (b)(4),implanted: (b)(6) 2010, product type: extension. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37743, serial# (b)(4), product type: programmer, patient. Product id: 37752, serial# (b)(4), product type: recharger. (b)(4).
 
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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
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5595792
MDR Text Key101423990
Report Number3004209178-2016-08006
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
Report Date 04/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2011
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 Received03/28/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2010
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: 04/21/2016 Patient Sequence Number: 1
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