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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulse generator, external pacemaker, dual chamber
Definition A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.
Product CodeOVJ
Regulation Number 870.3600
Device Class 2

MDR Year MDR Reports MDR Events
2017 6 6
2018 9 9
2019 1 1
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 6 6
Defective Device 4 4
Blocked Connection 2 2
Device Sensing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Failure to Power Up 2 2
Material Puncture/Hole 1 1
Premature Discharge of Battery 1 1
Pacing Problem 1 1
Pacemaker Found in Back-Up Mode 1 1
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9 9
No Code Available 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Death 2 2
Ventricular Fibrillation 1 1
Cardiac Arrest 1 1

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