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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)
2020 2021 2022 2023 2024 2025 2026
0 0 0 0 0 5 1

MDR Year MDR Reports MDR Events
2025 43 43
2026 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 17 17
Adverse Event Without Identified Device or Use Problem 14 14
Insufficient Information 10 10
Communication or Transmission Problem 10 10
Electrical /Electronic Property Problem 9 9
Power Problem 7 7
Erratic or Intermittent Display 4 4
Intermittent Capture 3 3
Failure to Capture 2 2
Image Orientation Incorrect 2 2
Pacing Inadequately 2 2
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Intermittent Communication Failure 1 1
Failure to Sense 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 61 61
Post Traumatic Wound Infection 6 6
Hematoma 4 4
Pocket Erosion 3 3
Wound Dehiscence 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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