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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, cochlear
Product CodeMCM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
17 17 19 21 27 21 28 23 23 15

Device Problems
Device operates differently than expected 1039
No code available 1012
Explanted 782
Device remains implanted 433
No device output 379
No Information 230
Migration of device or device component 205
Electrode(s), failure of 175
No Known Device Problem 164
Extrusion 124
Device stops intermittently 113
Device Issue 103
Improper or incorrect procedure or method 74
Implant extrusion 55
Malposition of device 35
Electrode(s), migration of 35
High impedance 35
Device inoperable 31
Dislodged or dislocated 22
Battery issue 20
Leak 15
Mechanical issue 13
Unknown (for use when the device problem is not known) 13
Implant, repositioning of 12
Noise, Audible 11
Therapeutic or diagnostic output failure 11
Break 10
Slippage of device or device component 9
Output issue 9
Unintended movement 8
Battery failure 8
Difficult to insert 8
Product quality issue 7
Connection issue 7
Electrical shorting 6
Human-Device Interface Issue 5
Impedance issue 5
Device displays error message 5
Use of Device Issue 5
Circuit Failure 5
Replace 4
Folded 4
Implant, removal of 4
Positioning Issue 4
Material Protrusion 4
Programming issue 4
Operating system version or upgrade problem 3
Inappropriate shock 3
Repair 3
Kinked 3
Biofilm coating in device 2
Elective removal 2
Failure to sense 2
Fitting problem 2
End of prosthetic life 2
Defective item 2
Patient-device incompatibility 2
Ambient noise issue 2
Output below specifications 2
Mechanics altered 2
Improper device output 2
Difficult to advance 2
Scratched material 2
Electromagnetic compatibility issue 1
Power source issue 1
Pressure issue 1
Device markings issue 1
Cut in material 1
High Readings 1
Retraction problem 1
Unexpected therapeutic results 1
Loss of threshold 1
Twisting 1
Vibration 1
Failure to osseointegrate 1
No voice prompts 1
Low impedance 1
Intermittent shock 1
Component missing 1
Electrical issue 1
Fracture 1
Intermittent continuity 1
Crack 1
Degraded 1
Disconnection 1
Displacement 1
Electro-magnetic interference (EMI) 1
Loose or intermittent connection 1
Moisture damage 1
Nonstandard device or device component 1
Unintended collision 1
Overheating of device or device component 1
Failure to pace or properly pace 1
Performance 1
Total Device Problems 5331

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 3 1 1 1 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics Corporation II Oct-22-2012
2 Advanced Bionics Corporation II Dec-21-2010
3 Advanced Bionics LLC II Sep-11-2009
4 Advanced Bionics LLC II Feb-03-2009
5 Cochlear Americas Inc. II Jul-20-2015
6 Cochlear Americas Inc. II Oct-03-2011
7 Cochlear Americas Inc. II Nov-02-2009

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