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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 111
No Known Device Problem 101
Failure to deliver energy 56
High impedance 46
Device displays error message 43
Low battery 32
Break 29
Battery issue 28
Migration of device or device component 27
Premature discharge of battery 25
Communication or transmission issue 25
Low impedance 25
Inappropriate shock 24
Charging issue 22
Intermittent continuity 18
Electromagnetic compatibility issue 17
Malposition of device 16
Delayed charge time 12
Impedance issue 11
Electro-magnetic interference (EMI) 10
Unintended collision 9
Overheating of device or device component 8
Improper or incorrect procedure or method 8
Failure to interrogate 8
Unexpected therapeutic results 5
Pocket stimulation 5
Therapy delivered to incorrect body area 4
Unstable 4
Electro-static discharge 3
Connection issue 3
Incorrect display 3
Material deformation 3
Material integrity issue 2
Positioning Issue 2
Noise, Audible 2
Difficult to insert 2
Bent 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
Shipping damage or problem 1
Disconnection 1
Loss of Data 1
Deployment issue 1
Device or device fragments location unknown 1
Cut in material 1
Use of Device Issue 1
Vibration 1
Material twisted 1
Environmental control or utility issue 1
Foreign material present in device 1
Total Device Problems 768

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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