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TPLC
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Device
analyzer, pacemaker generator function
Regulation Description
Pacemaker generator function analyzer.
Product Code
DTC
Regulation Number
870.3630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
1
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
100
100
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
218
218
Communication or Transmission Problem
126
126
Display or Visual Feedback Problem
106
106
Computer Operating System Problem
75
75
Device Difficult to Program or Calibrate
49
49
Output Problem
31
31
Pacing Problem
29
29
Device Sensing Problem
28
28
Data Problem
24
24
Device Displays Incorrect Message
15
15
Capturing Problem
13
13
Failure to Interrogate
12
12
Inadequate User Interface
11
11
Failure to Capture
9
9
Impedance Problem
8
8
Unexpected Shutdown
6
6
High impedance
5
5
Under-Sensing
4
4
Incorrect, Inadequate or Imprecise Resultor Readings
3
3
Unable to Obtain Readings
3
3
Inappropriate/Inadequate Shock/Stimulation
2
2
Power Problem
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Over-Sensing
2
2
Connection Problem
2
2
Application Program Problem
2
2
Appropriate Term/Code Not Available
2
2
Noise, Audible
1
1
Wireless Communication Problem
1
1
Program or Algorithm Execution Problem
1
1
Problem with Software Installation
1
1
Device Operational Issue
1
1
Signal Artifact/Noise
1
1
Failure to Sense
1
1
Mechanical Problem
1
1
Image Display Error/Artifact
1
1
Reset Problem
1
1
Battery Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
225
225
No Clinical Signs, Symptoms or Conditions
197
197
No Consequences Or Impact To Patient
76
76
No Patient Involvement
15
15
Cardiac Arrest
3
3
Bradycardia
2
2
Asystole
2
2
Atrial Fibrillation
1
1
Shock
1
1
Loss of consciousness
1
1
Shock from Patient Lead(s)
1
1
Non specific EKG/ECG Changes
1
1
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