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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 45
Failure to deliver energy 31
High impedance 26
Device displays error message 21
Break 19
Battery issue 18
Low battery 15
Premature discharge of battery 13
Low impedance 12
Charging issue 12
Communication or transmission issue 11
Inappropriate shock 11
Electromagnetic compatibility issue 10
Malposition of device 9
Migration of device or device component 7
Overheating of device or device component 6
Delayed charge time 6
Electro-magnetic interference (EMI) 5
Unintended collision 4
Intermittent continuity 4
Unexpected therapeutic results 4
Impedance issue 4
Use of Device Issue 3
Incorrect display 3
Improper or incorrect procedure or method 3
Material deformation 2
Material integrity issue 2
No device output 2
Pocket stimulation 2
Therapy delivered to incorrect body area 2
Unstable 2
Connection issue 2
Loss of Data 1
Manufacturing or shipping issue associated with device 1
Vibration 1
Device or device fragments location unknown 1
Cut in material 1
Difficult to remove 1
Difficult to Program or Calibrate 1
Disconnection 1
Bent 1
Difficult to insert 1
Failure to interrogate 1
Material twisted 1
Total Device Problems 381

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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