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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, auditory brainstem
Product CodeMHE
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 0 0 5 8 8 7 4 2 2 4 0

MDR Year MDR Reports MDR Events
2015 4 4
2016 9 9
2017 7 7
2018 1 1
2019 11 11
2020 5 5
2021 12 12
2022 6 6
2023 7 7
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 34 34
Adverse Event Without Identified Device or Use Problem 12 12
No Device Output 8 8
Insufficient Information 4 4
Migration or Expulsion of Device 4 4
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hearing Impairment 14 14
No Code Available 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 4 4
Deafness 4 4
Unspecified Infection 3 3
Pain 3 3
Cerebrospinal Fluid Leakage 2 2
Failure of Implant 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
Swelling 1 1
Meningitis 1 1
Headache 1 1
Intracranial Hemorrhage 1 1

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