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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable pulse generator
Definition Deliver Cardiac Contractility Modulation signals during the absolute refractory period
Product CodeQFV
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
4 5 9 10 5 2

MDR Year MDR Reports MDR Events
2022 1 1
2023 24 24
2024 45 45
2025 31 31
2026 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 42 42
Computer Software Problem 26 26
Failure to Charge 16 16
Prophylactic removal due to corrective action 5 5
Misassembly by Users 5 5
Aborted Charge 4 4
Insufficient Device Problem Information 4 4
Signal Artifact/Noise 2 2
Failure to Interrogate 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Charging Problem 2 2
Under-Sensing 2 2
Failure to Deliver Energy 1 1
Interrogation Problem 1 1
High impedance 1 1
Mechanical Problem 1 1
Extracardiac stimulation 1 1
Defective Component 1 1
Battery Problem 1 1
Impedance Problem 1 1
Device Difficult to Setup or Prepare 1 1
Device Sensing Problem 1 1
Installation-Related Problem 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Electromagnetic Interference 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 37 37
No Clinical Signs, Symptoms or Conditions 30 30
Heart Failure/Congestive Heart Failure 8 8
Unspecified Infection 7 7
Chest Pain 4 4
Discomfort 4 4
Cardiovascular Dysfunction/Insufficiency 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Medical device site infection 3 3
Pain 3 3
Bacteremia 3 3
Bacterial Infection 3 3
Electric Shock 2 2
Sepsis 2 2
Fungal Infection 2 2
Diaphoresis 2 2
Shock from Patient Lead(s) 2 2
Atrial Fibrillation 2 2
Post Operative Wound Infection 2 2
Insufficient Information 2 2
Endocarditis 2 2
Respiratory Insufficiency 2 2
Skin Infection 1 1
Gastrointestinal Hemorrhage 1 1
Cognitive Changes 1 1
Pericardial Effusion 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Device Overstimulation of Tissue 1 1
Twiddlers Syndrome 1 1
Dehydration 1 1
Fall 1 1
Dysphagia/ Odynophagia 1 1
Tachycardia 1 1
Swelling/ Edema 1 1
Inadequate Pain Relief 1 1
Pocket Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 IMPULSE DYNAMICS (USA) INC II Feb-22-2024
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