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TPLC
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show TPLC since
2008
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2013
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2015
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2018
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2020
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2023
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Device
pulse-generator, single chamber, sensor driven, implantable
Product Code
LWO
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
5
1
3
4
3
0
MDR Year
MDR Reports
MDR Events
2018
1
1
2019
5
5
2020
16
16
2021
13
13
2022
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Premature Discharge of Battery
11
11
Failure to Interrogate
6
6
No Pacing
6
6
Failure to Capture
6
6
Battery Problem
3
3
Data Problem
3
3
Pacing Problem
3
3
Adverse Event Without Identified Device or Use Problem
2
2
High impedance
2
2
Incorrect Measurement
2
2
No Apparent Adverse Event
2
2
Appropriate Term/Code Not Available
2
2
Device Sensing Problem
2
2
Low impedance
2
2
Under-Sensing
2
2
Separation Failure
2
2
Interrogation Problem
2
2
Positioning Failure
1
1
Pacing Intermittently
1
1
Failure to Sense
1
1
Communication or Transmission Problem
1
1
Battery Problem: High Impedance
1
1
Excessive Heating
1
1
Misconnection
1
1
Over-Sensing
1
1
Pacemaker Found in Back-Up Mode
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Insufficient Information
1
1
Capturing Problem
1
1
Device Dislodged or Dislocated
1
1
Signal Artifact/Noise
1
1
Break
1
1
Loose or Intermittent Connection
1
1
Connection Problem
1
1
Impedance Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
24
24
No Known Impact Or Consequence To Patient
15
15
No Consequences Or Impact To Patient
2
2
Syncope
2
2
Discomfort
2
2
Arrhythmia
2
2
Syncope/Fainting
2
2
No Information
1
1
Dyspnea
1
1
Cardiac Arrest
1
1
Unspecified Infection
1
1
Dizziness
1
1
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