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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 107
No Known Device Problem 96
Failure to deliver energy 54
High impedance 46
Device displays error message 39
Low battery 32
Break 29
Battery issue 27
Premature discharge of battery 25
Low impedance 25
Migration of device or device component 24
Communication or transmission issue 23
Inappropriate shock 22
Charging issue 19
Electromagnetic compatibility issue 17
Malposition of device 16
Intermittent continuity 15
Delayed charge time 11
Impedance issue 10
Electro-magnetic interference (EMI) 9
Unintended collision 9
Overheating of device or device component 8
Improper or incorrect procedure or method 8
Failure to interrogate 7
Unexpected therapeutic results 5
Pocket stimulation 4
Therapy delivered to incorrect body area 4
Incorrect display 3
Connection issue 3
Material deformation 3
Material integrity issue 2
Noise, Audible 2
Unstable 2
Electro-static discharge 2
Difficult to insert 2
No device output 2
Difficult to Program or Calibrate 1
Unable to obtain readings 1
Difficult to remove 1
Incorrect or inadequate result 1
Disconnection 1
Bent 1
Cut in material 1
Use of Device Issue 1
Vibration 1
Loss of Data 1
Deployment issue 1
Device or device fragments location unknown 1
Positioning Issue 1
Material twisted 1
Environmental control or utility issue 1
Foreign material present in device 1
Total Device Problems 728

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 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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