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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)
2019 2020 2021 2022 2023 2024
1 3 4 3 2 0

MDR Year MDR Reports MDR Events
2019 5 5
2020 16 16
2021 12 12
2022 5 5
2023 17 17
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 15 15
Failure to Interrogate 11 11
No Pacing 9 9
Failure to Capture 8 8
Incorrect Measurement 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Interrogation Problem 4 4
Battery Problem 4 4
Data Problem 4 4
Pacing Problem 4 4
Over-Sensing 2 2
Loose or Intermittent Connection 2 2
Signal Artifact/Noise 1 1
Break 1 1
High impedance 1 1
Communication or Transmission Problem 1 1
Insufficient Information 1 1
Failure to Sense 1 1
Patient Device Interaction Problem 1 1
Impedance Problem 1 1
Misconnection 1 1
Pacing Intermittently 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Sensing Problem 1 1
No Apparent Adverse Event 1 1
Under-Sensing 1 1
Low impedance 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Pacemaker Found in Back-Up Mode 1 1
Connection Problem 1 1
Human-Device Interface Problem 1 1
Battery Problem: High Impedance 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 31 31
No Known Impact Or Consequence To Patient 15 15
Arrhythmia 5 5
Unspecified Infection 4 4
Discomfort 4 4
Syncope/Fainting 2 2
Syncope 2 2
Dizziness 2 2
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Wound Dehiscence 1 1
Fatigue 1 1
Perforation 1 1
Cardiac Arrest 1 1
Pocket Erosion 1 1

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