TPLC - Total Product Life Cycle

• Device: cochlear implant with combined electrical stimulation and acoustic amplification
• Definition: Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
• Product Code: PGQ
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
6	1	6	4	1	2

MDR Year	MDR Reports	MDR Events
2020	27	27
2021	28	28
2022	21	22
2023	27	27
2024	21	21
2025	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	66	66
Adverse Event Without Identified Device or Use Problem	24	25
Insufficient Information	14	14
Output Problem	12	12
Therapeutic or Diagnostic Output Failure	12	12
Migration	10	10
Circuit Failure	6	6
Impedance Problem	4	4
Device Dislodged or Dislocated	4	4
Expulsion	3	3
Electrical Shorting	2	2
No Apparent Adverse Event	2	2
Migration or Expulsion of Device	1	1
Patient-Device Incompatibility	1	1
Positioning Failure	1	1
Low impedance	1	1
Device Appears to Trigger Rejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	74	75
No Clinical Signs, Symptoms or Conditions	20	20
Insufficient Information	13	13
Hearing Impairment	9	9
Unspecified Infection	7	7
Patient Problem/Medical Problem	6	6
Pain	6	6
Head Injury	3	3
Failure of Implant	2	2
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Undesired Nerve Stimulation	2	2
Bacterial Infection	2	2
Tinnitus	2	2
No Code Available	1	1
Implant Pain	1	1
Inflammation	1	1
Abscess	1	1
Tissue Breakdown	1	1