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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)
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 87 87
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 58 58
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
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