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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)
2019
2020
2021
2022
2023
2024
4
3
4
5
9
3
MDR Year
MDR Reports
MDR Events
2020
1
1
2022
1
1
2023
24
24
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
25
25
Adverse Event Without Identified Device or Use Problem
5
5
Failure to Charge
5
5
Device Dislodged or Dislocated
1
1
Data Problem
1
1
Battery Problem
1
1
Impedance Problem
1
1
Insufficient Information
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Failure to Deliver Energy
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
31
31
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
Chest Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
IMPULSE DYNAMICS USA INC
II
Feb-22-2024
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