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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 4 3 4 5 9 3

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 24 24
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 24 24
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Charge 3 3
Insufficient Information 1 1
Data Problem 1 1
Failure to Deliver Energy 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Battery Problem 1 1
Device Dislodged or Dislocated 1 1
Impedance Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 28 28
Heart Failure/Congestive Heart Failure 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Respiratory Insufficiency 2 2
Unspecified Infection 2 2
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
Fungal Infection 1 1
Post Operative Wound Infection 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

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