• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Break (1069); Insufficient Information (3190)
Patient Problems Cerebrospinal Fluid Leakage (1772); Therapeutic Response, Decreased (2271); Reaction (2414)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 39565-30, serial# (b)(4), implanted: (b)(6) 2009, product type: lead. Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(4), ubd: 03-nov-2012, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for complex regional pain syndrome type 2 and spinal pain. It was reported that the device was removed a year and a half ago and originally the plan was to put another one in, but the patient had a bad reaction to surgery so they could not. The patient said the device was removed because it stopped working. The patient said she had a spinal leak and instead of troubleshooting they decided to take it all out. The patient said they thought maybe one lead had corroded. The patient said the device helped a lot, but it just stopped working. The patient said that they thought the lead inside of that was deteriorating and affecting the other lead. The patient stated 6 months before removal, which was 1. 5 years prior to the report, the ins was replaced which didn't fix it. The patient said they found one program that has some benefit in it. The patient said at one point they replaced the ins and that still didn't help with anything. The patient thought the lead was replaced 6 months before the battery was replaced. No further complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9119837
MDR Text Key161382575
Report Number3004209178-2019-18415
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
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2009
Device Model Number37712
Device Catalogue Number37712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/22/2009
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: 09/25/2019 Patient Sequence Number: 1
-
-