TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
25	20	24	18	17	4

MDR Year	MDR Reports	MDR Events
2020	4403	4403
2021	5260	5260
2022	5502	5502
2023	5730	5730
2024	5613	5616
2025	1359	1359

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	6125	6126
Appropriate Term/Code Not Available	5876	5876
Adverse Event Without Identified Device or Use Problem	4682	4682
Impedance Problem	4622	4622
Output Problem	3344	3344
Expulsion	1904	1904
Migration	1569	1569
Insufficient Information	1304	1304
Circuit Failure	935	935
Therapeutic or Diagnostic Output Failure	914	914
Positioning Failure	517	517
Device Dislodged or Dislocated	486	486
Device Appears to Trigger Rejection	399	399
Intermittent Communication Failure	383	383
No Device Output	378	378
Unexpected Therapeutic Results	325	325
Migration or Expulsion of Device	254	254
Output below Specifications	218	218
Material Protrusion/Extrusion	217	217
No Apparent Adverse Event	198	198
Patient Device Interaction Problem	182	182
Electrical /Electronic Property Problem	173	173
Fluid/Blood Leak	168	168
Malposition of Device	127	127
Electrical Shorting	123	123
Loose or Intermittent Connection	116	116
Electro-Static Discharge	94	94
Failure to Read Input Signal	84	84
Patient-Device Incompatibility	83	83
Melted	83	83
Inadequacy of Device Shape and/or Size	73	73
Overheating of Device	71	71
Positioning Problem	71	71
Device Handling Problem	64	64
Battery Problem	63	63
High impedance	55	55
Microbial Contamination of Device	50	50
Connection Problem	49	49
Noise, Audible	48	48
Failure to Deliver Shock/Stimulation	42	42
Improper or Incorrect Procedure or Method	41	41
No Audible Prompt/Feedback	37	37
Communication or Transmission Problem	33	33
Device Slipped	26	26
Sparking	25	25
Misconnection	23	23
Lack of Effect	22	22
Leak/Splash	22	22
Incorrect, Inadequate or Imprecise Result or Readings	22	22
Application Program Version or Upgrade Problem	20	20

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10050	10051
Failure of Implant	6337	6337
Insufficient Information	3036	3036
Unspecified Infection	2743	2743
No Clinical Signs, Symptoms or Conditions	2490	2492
Pain	1436	1436
Tissue Breakdown	1136	1136
Head Injury	656	656
Therapeutic Response, Decreased	541	541
Hearing Impairment	540	540
Swelling/ Edema	472	472
No Code Available	444	444
Wound Dehiscence	430	430
Skin Infection	421	421
Bacterial Infection	367	367
Implant Pain	304	304
Undesired Nerve Stimulation	296	296
No Known Impact Or Consequence To Patient	283	283
Dizziness	267	267
Necrosis	259	259
Skin Inflammation/ Irritation	221	221
Discomfort	213	213
Headache	205	205
No Information	189	189
Tinnitus	184	184
Post Operative Wound Infection	176	176
Meningitis	142	142
Inflammation	137	137
Fluid Discharge	125	125
Skin Tears	117	117
Purulent Discharge	116	116
Patient Problem/Medical Problem	111	111
Vertigo	107	107
Abscess	106	106
Erythema	87	87
Hematoma	87	87
Impaired Healing	74	74
Drug Resistant Bacterial Infection	74	74
Skin Erosion	71	71
Cerebrospinal Fluid Leakage	69	69
Swelling	60	60
Ossification	52	52
Fall	49	49
Ulcer	49	49
Therapeutic Effects, Unexpected	47	47
Cellulitis	36	36
Erosion	35	35
Granuloma	34	34
Burning Sensation	33	33
Electric Shock	32	32

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Bionics, LLC	III	Nov-25-2020
2	Advanced Bionics, LLC	II	May-15-2020
3	Advanced Bionics, LLC	III	Mar-04-2020
4	Advanced Bionics, LLC	III	Feb-18-2020
5	MED-EL Elektromedizinische Gereate, Gmbh	II	Jul-12-2024
6	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024