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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
Regulation Description External pacemaker pulse generator.
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
2022 1 1
2023 7 7
2024 3 3
2025 16 16
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 9 9
Therapeutic or Diagnostic Output Failure 8 8
No Device Output 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Battery Problem 4 4
Unexpected Shutdown 2 2
Insufficient Device Problem Information 2 2
High impedance 1 1
Failure to Convert to Back-Up 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
No Apparent Adverse Event 1 1
Pacing Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Arrest 16 16
No Clinical Signs, Symptoms or Conditions 10 10
Asystole 2 2
Unspecified Infection 1 1
Arrhythmia 1 1
Ventricular Tachycardia 1 1
Insufficient Information 1 1
Bradycardia 1 1
Tachycardia 1 1

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