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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, pacemaker generator function
Regulation Description Pacemaker generator function analyzer.
Product CodeDTC
Regulation Number 870.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
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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