• 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
No Known Device Problem 49
Device operates differently than expected 40
Failure to deliver energy 26
High impedance 21
Break 16
Device displays error message 16
Low battery 14
Battery issue 13
Premature discharge of battery 12
Communication or transmission issue 10
Electromagnetic compatibility issue 10
Malposition of device 9
Inappropriate shock 9
Charging issue 8
Migration of device or device component 7
Low impedance 6
Delayed charge time 5
Overheating of device or device component 5
Electro-magnetic interference (EMI) 4
Intermittent continuity 4
Unexpected therapeutic results 4
Impedance issue 4
Use of Device Issue 3
Unstable 2
No device output 2
Improper or incorrect procedure or method 2
Connection issue 2
Incorrect display 2
Pocket stimulation 2
Material deformation 2
Material integrity issue 2
Material twisted 1
Manufacturing or shipping issue associated with device 1
Difficult to Program or Calibrate 1
Therapy delivered to incorrect body area 1
Difficult to remove 1
Unintended collision 1
Disconnection 1
Bent 1
Difficult to insert 1
Failure to interrogate 1
Loss of Data 1
Device or device fragments location unknown 1
Cut in material 1
Vibration 1
Total Device Problems 325

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

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

-
-