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TPLC
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show TPLC since
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Device
analyzer, pacemaker generator function
Product Code
DTC
Regulation Number
870.3630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOTRONIK, INC.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2017
34
34
2018
22
22
2019
139
139
2020
189
189
2021
637
637
2022
228
228
2023
237
237
2024
234
234
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
665
665
Computer Operating System Problem
539
539
Display or Visual Feedback Problem
435
435
Communication or Transmission Problem
386
386
Capturing Problem
112
112
Device Difficult to Program or Calibrate
103
103
Data Problem
101
101
Failure to Interrogate
83
83
Output Problem
80
80
Pacing Problem
69
69
Device Sensing Problem
65
65
Inadequate User Interface
42
42
Failure to Capture
19
19
Power Problem
17
17
Device Displays Incorrect Message
15
15
Impedance Problem
14
14
Over-Sensing
12
12
Unexpected Shutdown
10
10
Application Program Problem
9
9
Signal Artifact/Noise
8
8
Inappropriate/Inadequate Shock/Stimulation
7
7
Problem with Software Installation
6
6
Mechanical Problem
6
6
High impedance
5
5
Under-Sensing
5
5
Connection Problem
4
4
Loose or Intermittent Connection
4
4
Appropriate Term/Code Not Available
4
4
Unable to Obtain Readings
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Reset Problem
2
2
Battery Problem
2
2
Wireless Communication Problem
2
2
Program or Algorithm Execution Problem
1
1
Material Integrity Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
High Capture Threshold
1
1
Noise, Audible
1
1
Low impedance
1
1
Application Program Version or Upgrade Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Operational Issue
1
1
Failure to Power Up
1
1
Failure to Sense
1
1
Image Display Error/Artifact
1
1
Corroded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1417
1417
No Known Impact Or Consequence To Patient
225
225
No Consequences Or Impact To Patient
76
76
Asystole
19
19
No Patient Involvement
15
15
Cardiac Arrest
8
8
Arrhythmia
5
5
Shock from Patient Lead(s)
4
4
Tachycardia
3
3
Bradycardia
2
2
Heart Block
2
2
Shock
2
2
Insufficient Information
2
2
Dizziness
2
2
Loss of consciousness
2
2
Low Blood Pressure/ Hypotension
2
2
Fall
1
1
Syncope/Fainting
1
1
Undesired Nerve Stimulation
1
1
Atrial Fibrillation
1
1
Cardiac Tamponade
1
1
Pleural Effusion
1
1
Pericardial Effusion
1
1
Non specific EKG/ECG Changes
1
1
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