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)
2018 2019 2020 2021 2022 2023
5 1 3 4 3 0

MDR Year MDR Reports MDR Events
2018 1 1
2019 5 5
2020 16 16
2021 13 13
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 11 11
Failure to Interrogate 6 6
No Pacing 6 6
Failure to Capture 6 6
Battery Problem 3 3
Data Problem 3 3
Pacing Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
High impedance 2 2
Incorrect Measurement 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Device Sensing Problem 2 2
Low impedance 2 2
Under-Sensing 2 2
Separation Failure 2 2
Interrogation Problem 2 2
Positioning Failure 1 1
Pacing Intermittently 1 1
Failure to Sense 1 1
Communication or Transmission Problem 1 1
Battery Problem: High Impedance 1 1
Excessive Heating 1 1
Misconnection 1 1
Over-Sensing 1 1
Pacemaker Found in Back-Up Mode 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Insufficient Information 1 1
Capturing Problem 1 1
Device Dislodged or Dislocated 1 1
Signal Artifact/Noise 1 1
Break 1 1
Loose or Intermittent Connection 1 1
Connection Problem 1 1
Impedance Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 2 2
Syncope 2 2
Discomfort 2 2
Arrhythmia 2 2
Syncope/Fainting 2 2
No Information 1 1
Dyspnea 1 1
Cardiac Arrest 1 1
Unspecified Infection 1 1
Dizziness 1 1

-
-