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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)
2017 2018 2019 2020 2021 2022
6 5 1 3 4 3

MDR Year MDR Reports MDR Events
2017 3 3
2018 1 1
2019 5 5
2020 16 16
2021 13 13
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 10 10
Failure to Interrogate 7 7
Failure to Capture 5 5
Pacing Problem 5 5
No Pacing 5 5
Battery Problem 4 4
Appropriate Term/Code Not Available 3 3
Data Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Interrogation Problem 2 2
Incorrect Measurement 2 2
Misconnection 1 1
Over-Sensing 1 1
Loose or Intermittent Connection 1 1
High impedance 1 1
Break 1 1
Pacemaker Found in Back-Up Mode 1 1
Pacing Intermittently 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Failure to Sense 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Under-Sensing 1 1
Low impedance 1 1
Decreased Sensitivity 1 1
Excessive Heating 1 1
Signal Artifact/Noise 1 1
No Apparent Adverse Event 1 1
Insufficient Information 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
Impedance Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 16 16
Syncope/Fainting 2 2
Dyspnea 2 2
Syncope 2 2
Arrhythmia 2 2
Dizziness 2 2
No Consequences Or Impact To Patient 2 2
Discomfort 2 2
Cardiac Arrest 1 1
Unspecified Infection 1 1
Nausea 1 1
Weakness 1 1
No Information 1 1

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