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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Numbness (2415)
Event Date 07/28/2009
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Patient reports burning pain about 6" above their ins. Also reports acute pain and numbness around the belly button. This was reported to have occurred immediately following the implant and coming out of anesthesia. The symptoms were in the back above the ins location and belly button. It was reported that the patient was at home and was "good. " the patient was just trying to figure out what was causing this pain and numbness and how long it took of nerves to regrow. It was reported that the patient had numerous ct scans, x-rays, and other tests to see if it was related other organs but everything had come back as normal. Additional information was received on 2017-03-27 from the consumer reporting that on (b)(6) 2009 the health care professional (hcp) ¿touched a nerve¿ but would not admit it and that it ¿took a year to recover. ¿ it was reported that it was unknown if the issues resolved and it was unknown if the patient would be contacting a hcp regarding this event.
 
Manufacturer Narrative
Information references the main component of the system and other applicable components are:: product id 39565-65, serial# (b)(4), implanted: (b)(6) 2009, product type: lead. Product id 37743, serial# (b)(4), product type: programmer, patient. Product id: 37752, serial# (b)(4), product type recharger.
 
Event Description
Additional information was received from the patient reporting that their issue of their burnign pain and numbenss for their nerve being "touched," during implant surgery had not been resolved. They were still having some pain. The patient had injections as a step taken to help resolve the nerve being touched, but the injections never eliminated the pain completely. The patient also reported their weight and their new address and phone number. No further complications were reported/anticipated.
 
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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 Key6442794
MDR Text Key102709622
Report Number3004209178-2017-06579
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
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 04/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2010
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 Received04/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/11/2009
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: 03/29/2017 Patient Sequence Number: 1
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