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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)
2021 2022 2023 2024 2025 2026
2 2 4 1 1 0

MDR Year MDR Reports MDR Events
2021 12 12
2022 6 7
2023 7 7
2024 7 7
2025 5 5
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 22 22
Adverse Event Without Identified Device or Use Problem 9 10
Insufficient Information 2 2
Unexpected Therapeutic Results 2 2
No Device Output 2 2
Circuit Failure 1 1
Output Problem 1 1
Impedance Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Deliver Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Clinical Signs, Symptoms or Conditions 7 7
Failure of Implant 5 5
Unspecified Infection 4 5
Insufficient Information 4 4
Hearing Impairment 3 3
Solid Tumour 2 2
Implant Pain 2 2
Swelling/ Edema 2 2
Pain 1 1

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