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	15

MDR Year	MDR Reports	MDR Events
2020	4403	4403
2021	5260	5260
2022	5502	5503
2023	5727	5728
2024	5602	5605
2025	4576	4576

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	6635	6635
Appropriate Term/Code Not Available	6478	6478
Adverse Event Without Identified Device or Use Problem	5260	5260
Impedance Problem	4994	4994
Output Problem	3461	3461
Expulsion	2194	2194
Migration	1844	1844
Insufficient Information	1406	1406
Circuit Failure	1096	1096
Therapeutic or Diagnostic Output Failure	1033	1033
Positioning Failure	606	606
Device Dislodged or Dislocated	544	544
Device Appears to Trigger Rejection	445	445
Intermittent Communication Failure	427	427
No Device Output	407	407
Unexpected Therapeutic Results	382	382
Migration or Expulsion of Device	272	272
No Apparent Adverse Event	224	224
Output below Specifications	218	218
Material Protrusion/Extrusion	217	217
Fluid/Blood Leak	202	202
Electrical /Electronic Property Problem	194	194
Patient Device Interaction Problem	187	188
Loose or Intermittent Connection	157	157
Electrical Shorting	154	154
Malposition of Device	137	137
Failure to Read Input Signal	115	115
Electro-Static Discharge	104	104
Patient-Device Incompatibility	102	103
Failure to Deliver Shock/Stimulation	95	95
Melted	91	91
Inadequacy of Device Shape and/or Size	86	86
Overheating of Device	83	83
Device Handling Problem	80	80
Positioning Problem	74	74
Battery Problem	73	73
High impedance	65	65
Microbial Contamination of Device	59	59
Noise, Audible	53	53
Connection Problem	49	49
Signal Artifact/Noise	48	48
Improper or Incorrect Procedure or Method	43	43
No Audible Prompt/Feedback	37	37
Communication or Transmission Problem	33	33
Sparking	33	33
Lack of Effect	29	29
Device Slipped	26	26
Leak/Splash	24	24
Misconnection	23	23
Increased Sensitivity	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11292	11292
Failure of Implant	6891	6892
No Clinical Signs, Symptoms or Conditions	3281	3283
Insufficient Information	3132	3132
Unspecified Infection	2967	2967
Pain	1673	1674
Tissue Breakdown	1326	1326
Head Injury	876	876
Swelling/ Edema	577	578
Therapeutic Response, Decreased	541	541
Hearing Impairment	540	540
Wound Dehiscence	477	477
Skin Infection	446	446
No Code Available	444	444
Bacterial Infection	403	403
Implant Pain	380	381
Undesired Nerve Stimulation	362	362
Dizziness	354	354
Necrosis	304	304
Discomfort	287	287
No Known Impact Or Consequence To Patient	283	283
Skin Inflammation/ Irritation	263	264
Headache	261	261
Tinnitus	216	216
Post Operative Wound Infection	196	196
No Information	189	189
Fluid Discharge	165	165
Meningitis	156	156
Inflammation	155	155
Skin Tears	143	143
Purulent Discharge	143	143
Vertigo	141	141
Abscess	133	133
Patient Problem/Medical Problem	111	111
Hematoma	102	102
Erythema	98	98
Impaired Healing	97	97
Skin Erosion	88	88
Drug Resistant Bacterial Infection	88	88
Cerebrospinal Fluid Leakage	79	79
Fall	71	71
Swelling	60	60
Ulcer	58	58
Ossification	55	55
Therapeutic Effects, Unexpected	47	47
Electric Shock	42	42
Cellulitis	42	42
Seroma	39	39
Burning Sensation	38	38
Erosion	37	37

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Bionics, LLC	II	May-22-2025
2	Advanced Bionics, LLC	III	Nov-25-2020
3	Advanced Bionics, LLC	II	May-15-2020
4	Advanced Bionics, LLC	III	Mar-04-2020
5	Advanced Bionics, LLC	III	Feb-18-2020
6	MED-EL Elektromedizinische Gereate, Gmbh	II	Jul-12-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024