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	0

MDR Year	MDR Reports	MDR Events
2019	30	30
2020	27	27
2021	28	28
2022	22	22
2023	27	27
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	89	89
Adverse Event Without Identified Device or Use Problem	22	22
Insufficient Information	8	8
Output Problem	6	6
Therapeutic or Diagnostic Output Failure	5	5
Migration	4	4
Device Dislodged or Dislocated	4	4
Expulsion	3	3
Positioning Problem	1	1
Positioning Failure	1	1
Migration or Expulsion of Device	1	1
Low impedance	1	1
Patient-Device Incompatibility	1	1
Application Program Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	60	60
Hearing Impairment	28	28
No Clinical Signs, Symptoms or Conditions	13	13
Insufficient Information	7	7
Patient Problem/Medical Problem	6	6
Unspecified Infection	5	5
Pain	4	4
Head Injury	4	4
Bacterial Infection	3	3
No Code Available	3	3
Tissue Breakdown	3	3
Skin Inflammation/ Irritation	2	2
Discomfort	2	2
Undesired Nerve Stimulation	1	1
Wound Dehiscence	1	1
Headache	1	1
Implant Pain	1	1
No Known Impact Or Consequence To Patient	1	1
No Information	1	1

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