• 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 ADVANCED 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 ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37713
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Staphylococcus Aureus (2058); Sepsis (2067); Complaint, Ill-Defined (2331); Fluid Discharge (2686)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
Event date is an approximate. The patient noticed the surgery was contaminated and destroyed the unit in 2016. 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 failed back surgery syndrome. It was reported that the patient had the stimulator in until (b)(6) 2016. The patient explained that she had septic and stated that it destroyed the unit. The patient stated she also had a staph infection. The patient stated she had another surgery that was contaminated. The surgery had staph in it and it went unnoticed for 3 years. The patient said she almost got septic last year and almost died and they had to take everything out on (b)(6) 2016. The patient no longer has the stimulator implanted and said it was completely engrossed in staph. The patient said she did not know that the surgery was contaminated and had staph until they opened her up on (b)(6) 2016. The patient further stated that there was a bulge with drainage coming out. The patient said at her last surgery they had to correct everything, and she no longer can have an internal tens unit. The patient stated she still has severe back pain and the back pain was a preexisting issue. No further complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7258818
MDR Text Key99592068
Report Number3004209178-2018-02948
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
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2008
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 Received01/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/10/2007
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: 02/09/2018 Patient Sequence Number: 1
-
-