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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodePGQ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
4 3 6 1 6 0

MDR Year MDR Reports MDR Events
2018 14 14
2019 30 30
2020 27 27
2021 28 28
2022 22 22
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 90 90
Adverse Event Without Identified Device or Use Problem 22 22
Insufficient Information 8 8
Device Dislodged or Dislocated 4 4
Migration 4 4
Expulsion 3 3
Output Problem 2 2
Migration or Expulsion of Device 2 2
Low impedance 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 46
Hearing Impairment 36 36
No Clinical Signs, Symptoms or Conditions 9 9
Unspecified Infection 7 7
Patient Problem/Medical Problem 7 7
Insufficient Information 7 7
Head Injury 5 5
Bacterial Infection 3 3
Tissue Breakdown 3 3
No Code Available 3 3
Pain 3 3
Discomfort 2 2
Skin Inflammation/ Irritation 2 2
Implant Pain 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Wound Dehiscence 1 1
Headache 1 1
Necrosis 1 1
Necrosis Of Flap Tissue 1 1
Undesired Nerve Stimulation 1 1

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