TPLC - Total Product Life Cycle

• Device: implant, cochlear
• Product Code: MCM
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
17	17	19	21	27	21	8

Device Problems
Explanted	781
Device remains implanted	433
Electrode(s), failure of	175
Device operates differently than expected	104
Device Issue	99
No Information	63
Improper or incorrect procedure or method	60
Implant extrusion	55
Electrode(s), migration of	35
Migration of device or device component	22
Malposition of device	21
Extrusion	18
No Known Device Problem	16
Unknown (for use when the device problem is not known)	13
Implant, repositioning of	12
No device output	11
Leak	10
Mechanical issue	10
Battery failure	8
Device inoperable	6
Dislodged or dislocated	6
Circuit Failure	4
Use of Device Issue	4
Replace	4
No code available	4
Kinked	3
Difficult to insert	3
Repair	3
Implant, removal of	3
Connection issue	3
Human-Device Interface Issue	2
Ambient noise issue	2
Difficult to advance	2
Defective item	2
End of prosthetic life	2
Break	2
Elective removal	2
Folded	2
Performance	1
Crack	1
Failure to osseointegrate	1
Output issue	1
Loose or intermittent connection	1
Cut in material	1
Retraction problem	1
Displacement	1
Therapeutic or diagnostic output failure	1
Twisting	1
Fracture	1
High impedance	1
Total Device Problems	2017

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	3	1	1	1	0
Class III	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	Oct-03-2011
6	Cochlear Americas Inc.	II	Nov-02-2009