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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 9 4 10 11 4 3 6 1 6 4 0

MDR Year MDR Reports MDR Events
2014 1 1
2016 29 29
2017 26 26
2018 14 14
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 148 148
Adverse Event Without Identified Device or Use Problem 22 22
Insufficient Information 10 10
Output Problem 6 6
Therapeutic or Diagnostic Output Failure 5 5
Migration 4 4
Device Operates Differently Than Expected 4 4
Device Dislodged or Dislocated 4 4
Expulsion 3 3
Migration or Expulsion of Device 3 3
Patient-Device Incompatibility 2 2
Extrusion 2 2
Application Program Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Low impedance 1 1
Positioning Failure 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hearing Impairment 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 60 60
No Clinical Signs, Symptoms or Conditions 13 13
Pain 10 10
Unspecified Infection 10 10
Patient Problem/Medical Problem 9 9
Insufficient Information 7 7
No Information 7 7
Bacterial Infection 6 6
Head Injury 6 6
No Code Available 5 5
Dizziness 4 4
Tissue Breakdown 3 3
Skin Inflammation/ Irritation 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Therapeutic Effects, Unexpected 2 2
Headache 2 2
Wound Dehiscence 1 1
Abscess 1 1
Cellulitis 1 1
Facial Nerve Paralysis 1 1
Fever 1 1
Necrosis 1 1
Necrosis Of Flap Tissue 1 1
Undesired Nerve Stimulation 1 1
Skin Irritation 1 1
Swelling 1 1
Hearing Loss 1 1
Failure of Implant 1 1
Vertigo 1 1
No Known Impact Or Consequence To Patient 1 1
Electric Shock 1 1
Implant Pain 1 1

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