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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 125
No Known Device Problem 121
Failure to deliver energy 64
High impedance 59
Device displays error message 55
Low battery 36
Battery issue 33
Break 33
Migration of device or device component 30
Charging issue 30
Communication or transmission issue 29
Premature discharge of battery 29
Low impedance 26
Inappropriate shock 25
Intermittent continuity 21
Malposition of device 20
Electromagnetic compatibility issue 17
Impedance issue 16
Delayed charge time 15
Electro-magnetic interference (EMI) 11
Unintended collision 10
Overheating of device or device component 9
Improper or incorrect procedure or method 9
Failure to interrogate 8
Therapy delivered to incorrect body area 7
Unstable 6
Pocket stimulation 5
Unexpected therapeutic results 5
No device output 4
Incorrect display 3
Electro-static discharge 3
Connection issue 3
Material deformation 3
Material integrity issue 2
Positioning Issue 2
Noise, Audible 2
Unable to obtain readings 2
Difficult to insert 2
Bent 2
Disconnection 1
Energy output to patient tissue incorrect 1
Difficult to remove 1
Incorrect or inadequate result 1
Shipping damage or problem 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
Difficult to Program or Calibrate 1
Material twisted 1
Environmental control or utility issue 1
Foreign material present in device 1
Total Device Problems 897

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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