TPLC - Total Product Life Cycle

• Device: implantable pulse generator
• Definition: Deliver Cardiac Contractility Modulation signals during the absolute refractory period
• Product Code: QFV
• 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