TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
35	25	20	24	18	11

MDR Year	MDR Reports	MDR Events
2019	3406	3406
2020	4403	4403
2021	5260	5260
2022	5502	5502
2023	5730	5730
2024	3807	3809

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	6339	6339
Mechanical Problem	5511	5511
Adverse Event Without Identified Device or Use Problem	4496	4496
Impedance Problem	4337	4337
Output Problem	4129	4129
Expulsion	1680	1680
Migration	1574	1574
Insufficient Information	1340	1340
Therapeutic or Diagnostic Output Failure	999	999
Circuit Failure	833	833
Device Dislodged or Dislocated	535	535
No Device Output	501	501
Positioning Failure	431	431
Device Appears to Trigger Rejection	368	368
Intermittent Communication Failure	328	328
Migration or Expulsion of Device	306	306
Unexpected Therapeutic Results	299	299
Material Protrusion/Extrusion	269	269
Output below Specifications	222	222
Fluid/Blood Leak	198	198
Patient Device Interaction Problem	174	174
No Apparent Adverse Event	172	172
Electrical /Electronic Property Problem	156	156
Malposition of Device	124	124
Loose or Intermittent Connection	109	109
Patient-Device Incompatibility	100	100
Electrical Shorting	97	97
Electro-Static Discharge	89	89
Positioning Problem	77	77
Melted	73	73
Failure to Read Input Signal	73	73
Battery Problem	69	69
Inadequacy of Device Shape and/or Size	65	65
Device Handling Problem	55	55
High impedance	53	53
Overheating of Device	49	49
Connection Problem	49	49
Noise, Audible	48	48
Microbial Contamination of Device	42	42
Improper or Incorrect Procedure or Method	41	41
Communication or Transmission Problem	39	39
No Audible Prompt/Feedback	38	38
Device Slipped	37	37
Product Quality Problem	25	25
Sparking	24	24
Application Program Version or Upgrade Problem	23	23
Failure to Deliver Shock/Stimulation	23	23
Misconnection	23	23
Incorrect, Inadequate or Imprecise Result or Readings	22	22
Use of Device Problem	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8672	8672
Failure of Implant	6773	6773
Insufficient Information	2952	2952
Unspecified Infection	2693	2693
No Clinical Signs, Symptoms or Conditions	2184	2186
Pain	1547	1547
Hearing Impairment	1155	1155
Tissue Breakdown	970	970
No Code Available	910	910
Head Injury	629	629
Therapeutic Response, Decreased	557	557
No Known Impact Or Consequence To Patient	533	533
Swelling/ Edema	406	406
Wound Dehiscence	402	402
Skin Infection	397	397
Bacterial Infection	377	377
No Information	369	369
Undesired Nerve Stimulation	332	332
Implant Pain	257	257
Dizziness	257	257
Patient Problem/Medical Problem	238	238
Necrosis	224	224
Discomfort	220	220
Headache	214	214
Skin Inflammation/ Irritation	192	192
Post Operative Wound Infection	179	179
Tinnitus	168	168
Inflammation	151	151
Swelling	147	147
Meningitis	131	131
Purulent Discharge	113	113
Vertigo	107	107
Fluid Discharge	105	105
Skin Tears	98	98
Abscess	89	89
Erythema	86	86
Hematoma	83	83
Therapeutic Effects, Unexpected	75	75
Drug Resistant Bacterial Infection	66	66
Impaired Healing	64	64
Cerebrospinal Fluid Leakage	63	63
Skin Erosion	57	57
Ulcer	53	53
Ossification	53	53
Tissue Damage	40	40
Fall	40	40
Cellulitis	37	37
Erosion	34	34
Burning Sensation	31	31
No Consequences Or Impact To Patient	29	29

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	Advanced Bionics, LLC	II	Apr-03-2019
6	MED-EL Elektromedizinische Gereate, Gmbh	II	Jul-12-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024