• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device implantable pulse generator
Definition Deliver Cardiac Contractility Modulation signals during the absolute refractory period
Product CodeQFV
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
3 4 5 9 10 3

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 24 24
2024 45 45
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 26 26
Adverse Event Without Identified Device or Use Problem 19 19
Failure to Charge 8 8
Insufficient Information 2 2
Signal Artifact/Noise 1 1
Failure to Deliver Energy 1 1
Interrogation Problem 1 1
Failure to Interrogate 1 1
Aborted Charge 1 1
Defective Component 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Battery Problem 1 1
Impedance Problem 1 1
Misassembly by Users 1 1
Data Problem 1 1
Installation-Related Problem 1 1
Device Dislodged or Dislocated 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 6 6
Unspecified Infection 5 5
Heart Failure/Congestive Heart Failure 4 4
Chest Pain 3 3
Electric Shock 2 2
Fungal Infection 2 2
Diaphoresis 2 2
Atrial Fibrillation 2 2
Pain 2 2
Bacterial Infection 2 2
Respiratory Insufficiency 2 2
Sepsis 1 1
Gastrointestinal Hemorrhage 1 1
Cognitive Changes 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Post Operative Wound Infection 1 1
Insufficient Information 1 1
Dehydration 1 1
Dysphagia/ Odynophagia 1 1
Swelling/ Edema 1 1
Endocarditis 1 1
No Consequences Or Impact To Patient 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
-
-