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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
Device operates differently than expected 32
No Known Device Problem 31
High impedance 20
Failure to deliver energy 16
Device displays error message 13
Low battery 10
Premature discharge of battery 9
Communication or transmission issue 9
Inappropriate shock 9
Battery issue 6
Charging issue 6
Break 6
Overheating of device or device component 5
Delayed charge time 5
Low impedance 5
Electromagnetic compatibility issue 5
Intermittent continuity 3
Use of Device Issue 3
Unexpected therapeutic results 3
Migration of device or device component 3
Malposition of device 3
Impedance issue 3
Electro-magnetic interference (EMI) 3
Material deformation 2
Incorrect display 2
Pocket stimulation 2
Unstable 1
Vibration 1
Improper or incorrect procedure or method 1
Loss of Data 1
Material integrity issue 1
Difficult to remove 1
Bent 1
Material twisted 1
Failure to interrogate 1
Difficult to Program or Calibrate 1
Connection issue 1
No device output 1
Cut in material 1
Device or device fragments location unknown 1
Manufacturing or shipping issue associated with device 1
Disconnection 1
Difficult to insert 1
Unintended collision 1
Therapy delivered to incorrect body area 1
Total Device Problems 233

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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