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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 112
No Known Device Problem 89
Failure to deliver energy 51
High impedance 48
Device displays error message 41
Break 29
Battery issue 29
Low impedance 28
Low battery 27
Premature discharge of battery 27
Charging issue 24
Communication or transmission issue 23
Migration of device or device component 23
Inappropriate shock 20
Malposition of device 16
Electromagnetic compatibility issue 16
Delayed charge time 15
Impedance issue 10
Overheating of device or device component 9
Intermittent continuity 9
Electro-magnetic interference (EMI) 8
Unintended collision 8
Improper or incorrect procedure or method 7
Failure to interrogate 6
Unexpected therapeutic results 5
Connection issue 5
Pocket stimulation 4
Therapy delivered to incorrect body area 3
Incorrect display 3
Unstable 3
Use of Device Issue 3
Material deformation 3
Material integrity issue 3
Noise, Audible 2
Incorrect or inadequate result 2
Difficult to insert 2
No device output 2
Unable to obtain readings 1
Difficult to remove 1
Failure to power-up 1
Difficult to Program or Calibrate 1
Disconnection 1
Bent 1
Electro-static discharge 1
Vibration 1
Loss of Data 1
Device or device fragments location unknown 1
Cut in material 1
Material twisted 1
Positioning Issue 1
Manufacturing or shipping issue associated with device 1
Environmental control or utility issue 1
Foreign material present in device 1
Total Device Problems 731

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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