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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device outpatient cardiac telemetry
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Definition Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.
Product CodeQYX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMEDIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1
VIVAQUANT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 74 100
2024 400 459
2025 110 110
2026 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Transmit Record 518 602
Patient-Device Incompatibility 51 52
Adverse Event Without Identified Device or Use Problem 16 16
Inaccurate Information 11 13
Use of Device Problem 5 5
Insufficient Information 2 2
Patient Data Problem 2 2
Communication or Transmission Problem 1 1
Wireless Communication Problem 1 1
Unclear Information 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Heart Problem 536 620
Skin Inflammation/ Irritation 31 31
Hypersensitivity/Allergic reaction 13 13
Insufficient Information 12 12
Contact Dermatitis 7 8
Skin Infection 6 6
No Clinical Signs, Symptoms or Conditions 2 2
Anaphylactoid 2 2
Burn(s) 2 2
Stroke/CVA 2 2
Chest Pain 1 1
Erythema 1 1
Cellulitis 1 2
Itching Sensation 1 1
Pain 1 1
Scar Tissue 1 1
Caustic/Chemical Burns 1 1
Syncope/Fainting 1 1
Heart Block 1 1
Skin Burning Sensation 1 1

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