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	16

MDR Year	MDR Reports	MDR Events
2019	3406	3406
2020	4403	4403
2021	5260	5260
2022	5502	5502
2023	5730	5730
2024	5174	5177

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	6605	6605
Mechanical Problem	5781	5782
Adverse Event Without Identified Device or Use Problem	4732	4732
Impedance Problem	4498	4498
Output Problem	4173	4173
Expulsion	1816	1816
Migration	1675	1675
Insufficient Information	1379	1379
Therapeutic or Diagnostic Output Failure	1029	1029
Circuit Failure	903	903
Device Dislodged or Dislocated	559	559
No Device Output	511	511
Positioning Failure	464	464
Device Appears to Trigger Rejection	386	386
Intermittent Communication Failure	349	349
Unexpected Therapeutic Results	317	317
Migration or Expulsion of Device	307	307
Material Protrusion/Extrusion	269	269
Output below Specifications	222	222
Fluid/Blood Leak	208	208
No Apparent Adverse Event	183	183
Patient Device Interaction Problem	174	174
Electrical /Electronic Property Problem	160	160
Malposition of Device	135	135
Loose or Intermittent Connection	115	115
Electrical Shorting	105	105
Patient-Device Incompatibility	105	105
Electro-Static Discharge	89	89
Positioning Problem	83	83
Failure to Read Input Signal	77	77
Melted	77	77
Battery Problem	70	70
Inadequacy of Device Shape and/or Size	66	66
Device Handling Problem	61	61
High impedance	53	53
Overheating of Device	52	52
Connection Problem	51	51
Noise, Audible	49	49
Microbial Contamination of Device	45	45
Improper or Incorrect Procedure or Method	45	45
Communication or Transmission Problem	39	39
No Audible Prompt/Feedback	38	38
Device Slipped	37	37
Failure to Deliver Shock/Stimulation	36	36
Product Quality Problem	25	25
Sparking	25	25
Application Program Version or Upgrade Problem	23	23
Misconnection	23	23
Use of Device Problem	22	22
Thermal Decomposition of Device	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9285	9286
Failure of Implant	7031	7031
Insufficient Information	2986	2986
Unspecified Infection	2849	2849
No Clinical Signs, Symptoms or Conditions	2289	2291
Pain	1624	1624
Hearing Impairment	1155	1155
Tissue Breakdown	1060	1060
No Code Available	910	910
Head Injury	663	663
Therapeutic Response, Decreased	557	557
No Known Impact Or Consequence To Patient	533	533
Swelling/ Edema	437	437
Wound Dehiscence	418	418
Skin Infection	408	408
Bacterial Infection	400	400
No Information	369	369
Undesired Nerve Stimulation	348	348
Dizziness	279	279
Implant Pain	277	277
Necrosis	244	244
Patient Problem/Medical Problem	238	238
Discomfort	231	231
Headache	224	224
Skin Inflammation/ Irritation	201	201
Post Operative Wound Infection	182	182
Tinnitus	180	180
Inflammation	152	152
Meningitis	151	151
Swelling	147	147
Fluid Discharge	118	118
Purulent Discharge	117	117
Vertigo	112	112
Skin Tears	104	104
Abscess	100	100
Erythema	91	91
Hematoma	84	84
Therapeutic Effects, Unexpected	75	75
Cerebrospinal Fluid Leakage	74	74
Drug Resistant Bacterial Infection	70	70
Impaired Healing	67	67
Skin Erosion	62	62
Ulcer	54	54
Ossification	54	54
Fall	43	43
Tissue Damage	40	40
Cellulitis	39	39
Erosion	35	35
Burning Sensation	33	33
Granuloma	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	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