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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
2019 1 1
2020 1 1
2022 1 1
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
No Pacing 2 2
Output Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Battery Problem 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Arrest 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Arrhythmia 1 1
Bradycardia 1 1
Unspecified Infection 1 1
Tachycardia 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Asystole 1 1
Insufficient Information 1 1

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