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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 2017
17 17 19 21 27 21 28 23 23 25 28

Device Problems
Device operates differently than expected 2298
No code available 1992
Explanted 782
No device output 654
Device remains implanted 433
Migration of device or device component 340
No Information 328
No Known Device Problem 299
Extrusion 286
Electrode(s), failure of 175
Device stops intermittently 151
Device Issue 106
Improper or incorrect procedure or method 83
Implant extrusion 55
High impedance 36
Electrode(s), migration of 35
Malposition of device 35
Device inoperable 31
Battery issue 31
Dislodged or dislocated 24
Leak 16
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
Impedance issue 8
Unintended movement 8
Battery failure 8
Difficult to insert 8
Product quality issue 7
Folded 7
Connection issue 7
Electrical shorting 6
Human-Device Interface Issue 5
Patient-device incompatibility 5
Device displays error message 5
Use of Device Issue 5
Circuit Failure 5
Kinked 4
Replace 4
Implant, removal of 4
Material Protrusion 4
Positioning Issue 4
Programming issue 4
Operating system version or upgrade problem 3
Inappropriate shock 3
Repair 3
Overheating of device or device component 2
Biofilm coating in device 2
Elective removal 2
Failure to sense 2
Fitting problem 2
End of prosthetic life 2
Defective item 2
Ambient noise issue 2
Output below specifications 2
Scratched material 2
Mechanics altered 2
Improper device output 2
Difficult to advance 2
Device markings issue 1
Electromagnetic compatibility issue 1
Power source issue 1
Pressure issue 1
Loss of osseointegration 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
Fire 1
Fracture 1
Intermittent continuity 1
Crack 1
Degraded 1
Disconnection 1
Displacement 1
Electro-magnetic interference (EMI) 1
Failure to pace or properly pace 1
Performance 1
Loose or intermittent connection 1
Moisture damage 1
Nonstandard device or device component 1
Unintended collision 1
Total Device Problems 8453

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 3 1 1 1 0 0 1 0 0
Class III 0 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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