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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse-generator, single chamber, sensor driven, implantable
Product CodeLWO
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
5 7 10 1 0 0 0 1 6 5 1 3 4 3 2 0

MDR Year MDR Reports MDR Events
2014 3 3
2015 2 2
2016 1 1
2017 3 3
2018 1 1
2019 5 5
2020 16 16
2021 12 12
2022 5 5
2023 17 17
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 15 15
Failure to Interrogate 14 14
Failure to Capture 8 8
Pacing Problem 8 8
No Pacing 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Incorrect Measurement 6 6
Battery Problem 5 5
Interrogation Problem 4 4
Data Problem 3 3
Appropriate Term/Code Not Available 2 2
Over-Sensing 2 2
Loose or Intermittent Connection 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Under-Sensing 1 1
Low impedance 1 1
Decreased Sensitivity 1 1
Pacemaker Found in Back-Up Mode 1 1
Pacing Intermittently 1 1
Therapy Delivered to Incorrect Body Area 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Sense 1 1
Misconnection 1 1
High impedance 1 1
Break 1 1
Signal Artifact/Noise 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Capturing Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Device Sensing Problem 1 1
Battery Problem: High Impedance 1 1
Human-Device Interface Problem 1 1
Impedance Problem 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 19 19
Arrhythmia 5 5
Unspecified Infection 5 5
Discomfort 3 3
Syncope/Fainting 2 2
Syncope 2 2
Dizziness 2 2
No Consequences Or Impact To Patient 2 2
Wound Dehiscence 1 1
Insufficient Information 1 1
No Information 1 1
No Code Available 1 1
Nausea 1 1
Perforation 1 1
Pocket Erosion 1 1
Weakness 1 1
Cardiac Arrest 1 1
Dyspnea 1 1
Fainting 1 1
Fall 1 1
Fatigue 1 1
Bone Fracture(s) 1 1

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