• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device implanted subcortical electrical stimulator (motor disorders)
Product CodeMRU
Device Class Humanitarian Device Exemption

Device Problems
Device operates differently than expected 103
No Known Device Problem 94
Failure to deliver energy 52
High impedance 43
Device displays error message 37
Low battery 32
Break 28
Battery issue 27
Premature discharge of battery 25
Migration of device or device component 24
Low impedance 24
Communication or transmission issue 22
Inappropriate shock 21
Charging issue 19
Electromagnetic compatibility issue 16
Malposition of device 16
Intermittent continuity 15
Delayed charge time 11
Impedance issue 10
Unintended collision 9
Overheating of device or device component 8
Electro-magnetic interference (EMI) 8
Improper or incorrect procedure or method 8
Failure to interrogate 6
Unexpected therapeutic results 5
Pocket stimulation 4
Therapy delivered to incorrect body area 3
Incorrect display 3
Connection issue 3
Material deformation 3
Material integrity issue 2
Noise, Audible 2
Unstable 2
Electro-static discharge 2
Difficult to insert 2
No device output 2
Difficult to Program or Calibrate 1
Unable to obtain readings 1
Difficult to remove 1
Incorrect or inadequate result 1
Disconnection 1
Bent 1
Cut in material 1
Use of Device Issue 1
Vibration 1
Loss of Data 1
Deployment issue 1
Device or device fragments location unknown 1
Positioning Issue 1
Material twisted 1
Environmental control or utility issue 1
Foreign material present in device 1
Total Device Problems 707

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation I May-01-2013

-
-