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