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 pulse-generator, single chamber, sensor driven, implantable
Product CodeLWO
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
4 3 2 1 5 0

MDR Year MDR Reports MDR Events
2021 12 12
2022 5 5
2023 16 16
2024 10 10
2025 10 10
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Interrogate 14 14
Premature Discharge of Battery 12 12
No Pacing 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Incorrect Measurement 6 6
Failure to Capture 5 5
Battery Problem 4 4
Interrogation Problem 3 3
Pacing Problem 3 3
Loose or Intermittent Connection 3 3
Break 2 2
Insufficient Information 2 2
Data Problem 2 2
Migration or Expulsion of Device 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Sensing Problem 1 1
No Apparent Adverse Event 1 1
Over-Sensing 1 1
Under-Sensing 1 1
Low impedance 1 1
Pacemaker Found in Back-Up Mode 1 1
Failure to Disconnect 1 1
Capturing Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
Arrhythmia 5 5
Insufficient Information 5 5
Unspecified Infection 4 4
Syncope/Fainting 3 3
Fatigue 3 3
Discomfort 3 3
Dizziness 2 2
Pocket Erosion 2 2
Wound Dehiscence 1 1
Failure of Implant 1 1

-
-