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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, autonomic nerve, implanted for stroke rehabilitation
Definition Stimulation of the vagus nerve
Product CodeQPY
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 1 0 2 4 3

MDR Year MDR Reports MDR Events
2023 4 4
2024 5 5
2025 6 6
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
High impedance 2 2
Insufficient Information 2 2
Use of Device Problem 2 2
Incomplete or Inadequate Connection 1 1
Unintended Movement 1 1
Failure to Interrogate 1 1
Lack of Effect 1 1
Misconnection 1 1
Migration 1 1
Low impedance 1 1
Appropriate Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Implant Pain 4 4
Discomfort 3 3
Unspecified Infection 2 2
Post Operative Wound Infection 2 2
Paresis 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Tissue Breakdown 1 1
Cough 1 1
Unspecified Musculoskeletal problem 1 1
Nerve Damage 1 1
Impaired Healing 1 1
Neck Pain 1 1

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