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TPLC
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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
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