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)
2019	2020	2021	2022	2023	2024
3	6	1	6	4	1

MDR Year	MDR Reports	MDR Events
2019	30	30
2020	27	27
2021	28	28
2022	22	22
2023	27	27
2024	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	91	91
Adverse Event Without Identified Device or Use Problem	22	22
Insufficient Information	10	10
Output Problem	7	7
Therapeutic or Diagnostic Output Failure	7	7
Migration	4	4
Device Dislodged or Dislocated	4	4
Expulsion	3	3
Migration or Expulsion of Device	1	1
Application Program Problem	1	1
Patient-Device Incompatibility	1	1
Positioning Problem	1	1
Positioning Failure	1	1
Low impedance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	63	63
Hearing Impairment	28	28
No Clinical Signs, Symptoms or Conditions	13	13
Insufficient Information	9	9
Unspecified Infection	7	7
Patient Problem/Medical Problem	6	6
Head Injury	4	4
Pain	4	4
No Code Available	3	3
Bacterial Infection	3	3
Tissue Breakdown	3	3
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Wound Dehiscence	1	1
No Information	1	1
Implant Pain	1	1
No Known Impact Or Consequence To Patient	1	1
Undesired Nerve Stimulation	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MED-EL Elektromedizinische Gereate, Gmbh	II	Aug-02-2019