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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implanted subcortical electrical stimulator (motor disorders)
Product CodeMRU
Device Class Humanitarian Device Exemption

Device Problems
No Known Device Problem 53
Device operates differently than expected 42
Failure to deliver energy 30
High impedance 25
Device displays error message 20
Break 18
Low battery 15
Battery issue 14
Premature discharge of battery 12
Communication or transmission issue 11
Charging issue 10
Electromagnetic compatibility issue 10
Malposition of device 9
Inappropriate shock 9
Low impedance 9
Migration of device or device component 7
Overheating of device or device component 6
Electro-magnetic interference (EMI) 5
Delayed charge time 5
Unexpected therapeutic results 4
Intermittent continuity 4
Impedance issue 4
Use of Device Issue 3
Improper or incorrect procedure or method 3
No device output 2
Unstable 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
Vibration 1
Cut in material 1
Total Device Problems 356

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

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