Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 16 16
Insufficient Information 9 9
Electrical /Electronic Property Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Power Problem 7 7
Communication or Transmission Problem 5 5
Erratic or Intermittent Display 4 4
Patient Device Interaction Problem 2 2
Intermittent Capture 2 2
Failure to Capture 2 2
Image Orientation Incorrect 2 2
Activation, Positioning or Separation Problem 1 1
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Battery Problem 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Heart Problem 47 47
Post Traumatic Wound Infection 5 5
Hematoma 3 3
Pocket Erosion 2 2
Wound Dehiscence 1 1
No Clinical Signs, Symptoms or Conditions 1 1

-
-