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TPLC
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Device
analyzer, pacemaker generator function
Product Code
DTC
Regulation Number
870.3630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
34
34
2018
22
22
2019
139
139
2020
189
189
2021
637
637
2022
228
228
2023
237
237
2024
491
491
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
730
730
Computer Operating System Problem
661
661
Display or Visual Feedback Problem
471
471
Communication or Transmission Problem
465
465
Capturing Problem
112
112
Data Problem
108
108
Device Difficult to Program or Calibrate
106
106
Output Problem
100
100
Failure to Interrogate
97
97
Pacing Problem
73
73
Device Sensing Problem
68
68
Inadequate User Interface
44
44
Failure to Capture
19
19
Device Displays Incorrect Message
18
18
Power Problem
17
17
Impedance Problem
14
14
Signal Artifact/Noise
13
13
Over-Sensing
12
12
Application Program Problem
11
11
Unexpected Shutdown
10
10
Inappropriate/Inadequate Shock/Stimulation
8
8
Problem with Software Installation
7
7
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
Failure to Power Up
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 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
1669
1669
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
7
7
Arrhythmia
5
5
Shock from Patient Lead(s)
5
5
Bradycardia
4
4
Tachycardia
3
3
Insufficient Information
3
3
Heart Block
2
2
Dizziness
2
2
Shock
2
2
Loss of consciousness
2
2
Low Blood Pressure/ Hypotension
2
2
Undesired Nerve Stimulation
1
1
Pleural Effusion
1
1
Pneumothorax
1
1
Atrial Fibrillation
1
1
Non specific EKG/ECG Changes
1
1
Fall
1
1
Cardiac Tamponade
1
1
Pericardial Effusion
1
1
Syncope/Fainting
1
1
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