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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)
2016 2017 2018 2019 2020 2021
10 11 4 3 6 1

MDR Year MDR Reports MDR Events
2016 29 29
2017 26 26
2018 14 14
2019 30 30
2020 27 27
2021 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 107 107
Adverse Event Without Identified Device or Use Problem 19 19
Insufficient Information 6 6
Device Operates Differently Than Expected 4 4
Migration or Expulsion of Device 3 3
Patient-Device Incompatibility 2 2
Positioning Failure 2 2
Expulsion 2 2
Extrusion 2 2
Low impedance 1 1
Positioning Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hearing Impairment 63 63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Patient Problem/Medical Problem 9 9
Unspecified Infection 8 8
No Information 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Pain 6 6
Bacterial Infection 6 6
Head Injury 6 6
Insufficient Information 5 5
No Code Available 5 5
Dizziness 4 4
Discomfort 2 2
Complaint, Ill-Defined 2 2
Tissue Breakdown 2 2
Therapeutic Effects, Unexpected 2 2
Skin Inflammation/ Irritation 2 2
Headache 2 2
Wound Dehiscence 1 1
Abscess 1 1
Cellulitis 1 1
Facial Nerve Paralysis 1 1
Fever 1 1
Skin Irritation 1 1
Swelling 1 1
Hearing Loss 1 1
Failure of Implant 1 1
Necrosis 1 1
Necrosis Of Flap Tissue 1 1
Undesired Nerve Stimulation 1 1
Implant Pain 1 1
Vertigo 1 1
No Known Impact Or Consequence To Patient 1 1

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