TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
20	24	18	17	17	6

MDR Year	MDR Reports	MDR Events
2021	5260	5277
2022	5502	5536
2023	5727	5757
2024	5602	5615
2025	5511	5511
2026	1755	1755

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	6411	6411
Appropriate Term/Code Not Available	5845	5899
Impedance Problem	5032	5032
Adverse Event Without Identified Device or Use Problem	4895	4905
Output Problem	2653	2654
Expulsion	2207	2229
Migration	1856	1856
Insufficient Information	1318	1326
Circuit Failure	1176	1176
Therapeutic or Diagnostic Output Failure	907	907
Positioning Failure	651	653
Device Dislodged or Dislocated	507	507
Device Appears to Trigger Rejection	486	488
Unexpected Therapeutic Results	449	449
Intermittent Communication Failure	430	430
No Device Output	310	310
Failure to Deliver Shock/Stimulation	223	223
No Apparent Adverse Event	222	223
Migration or Expulsion of Device	207	207
Patient Device Interaction Problem	191	195
Electrical Shorting	186	186
Loose or Intermittent Connection	186	186
Failure to Read Input Signal	185	185
Electrical /Electronic Property Problem	180	180
Fluid/Blood Leak	178	178
Material Protrusion/Extrusion	159	160
Malposition of Device	144	144
Inadequacy of Device Shape and/or Size	132	133
Signal Artifact/Noise	100	100
Device Handling Problem	98	98
Electro-Static Discharge	96	96
Patient-Device Incompatibility	95	96
Overheating of Device	89	89
Melted	82	82
Output below Specifications	77	77
High impedance	74	74
Lack of Effect	69	69
Battery Problem	69	69
Positioning Problem	60	60
Microbial Contamination of Device	58	58
Intermittent Shock/Stimulation	52	52
Connection Problem	50	50
Noise, Audible	48	48
Defibrillation/Stimulation Problem	35	35
Communication or Transmission Problem	33	33
Improper or Incorrect Procedure or Method	31	31
Sparking	31	31
Increased Sensitivity	28	28
No Audible Prompt/Feedback	24	24
Fire	23	23

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11799	11814
Failure of Implant	6449	6450
No Clinical Signs, Symptoms or Conditions	3611	3621
Insufficient Information	3005	3015
Unspecified Infection	2781	2815
Pain	1601	1607
Tissue Breakdown	1452	1478
Head Injury	842	843
Swelling/ Edema	639	642
Wound Dehiscence	489	502
Implant Pain	468	471
Skin Infection	449	457
Dizziness	378	379
Bacterial Infection	366	366
Undesired Nerve Stimulation	354	354
Discomfort	325	328
Necrosis	311	316
Skin Inflammation/ Irritation	281	282
Headache	279	280
Tinnitus	238	238
Fluid Discharge	206	206
Hearing Impairment	197	197
Post Operative Wound Infection	195	197
Purulent Discharge	162	162
Inflammation	160	160
Skin Tears	158	158
Meningitis	153	153
Vertigo	152	152
Abscess	140	143
Erythema	117	117
Impaired Healing	113	114
Skin Erosion	102	102
Drug Resistant Bacterial Infection	101	102
Fall	86	86
Hematoma	84	85
Cerebrospinal Fluid Leakage	79	79
Ulcer	57	57
Ossification	52	52
Electric Shock	49	49
Seroma	48	48
Therapeutic Response, Decreased	48	48
Erosion	43	44
Post Traumatic Wound Infection	41	41
Cellulitis	41	41
Fistula	41	41
Burning Sensation	38	38
Cyst(s)	36	36
Granuloma	33	36
Hemorrhage/Bleeding	32	33
Nausea	32	32

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Bionics, LLC	II	Apr-27-2026
2	Advanced Bionics, LLC	II	Mar-05-2026
3	Advanced Bionics, LLC	II	May-22-2025
4	MED-EL Elektromedizinische Gereate, Gmbh	II	Jul-12-2024
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024