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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device leadless cardiac resynchronization therapy (crt)
Definition Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant
Product CodeSEG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 0 5 0

MDR Year MDR Reports MDR Events
2025 43 43
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 16 16
Electrical /Electronic Property Problem 8 8
Insufficient Information 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Power Problem 5 5
Erratic or Intermittent Display 4 4
Communication or Transmission Problem 3 3
Image Orientation Incorrect 2 2
Failure to Capture 2 2
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Intermittent Communication Failure 1 1
Battery Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Heart Problem 39 39
Post Traumatic Wound Infection 4 4
Hematoma 2 2
Pocket Erosion 2 2
Wound Dehiscence 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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