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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)
2019 2020 2021 2022 2023 2024
7 4 2 2 4 0

MDR Year MDR Reports MDR Events
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 24 24
Adverse Event Without Identified Device or Use Problem 12 12
No Device Output 3 3
Insufficient Information 2 2
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hearing Impairment 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Clinical Signs, Symptoms or Conditions 6 6
No Code Available 6 6
Insufficient Information 4 4
Failure of Implant 2 2
Unspecified Infection 2 2
Pain 2 2
Cerebrospinal Fluid Leakage 2 2
Swelling 1 1

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