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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
2014 1 1
2017 34 34
2018 22 22
2019 139 139
2020 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 114 114
Communication or Transmission Problem 68 68
Display or Visual Feedback Problem 43 43
Computer Operating System Problem 40 40
Device Sensing Problem 23 23
Device Difficult to Program or Calibrate 21 21
Output Problem 21 21
Pacing Problem 19 19
Data Problem 16 16
Device Displays Incorrect Message 15 15
Failure to Capture 8 8
Impedance Problem 6 6
High impedance 5 5
Inadequate User Interface 5 5
Under-Sensing 4 4
Capturing Problem 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Application Program Problem 2 2
Appropriate Term/Code Not Available 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Over-Sensing 2 2
Connection Problem 2 2
Battery Problem 1 1
Power Problem 1 1
Reset Problem 1 1
Unable to Obtain Readings 1 1
Image Display Error/Artifact 1 1
Failure to Interrogate 1 1
Noise, Audible 1 1
Wireless Communication Problem 1 1
Unexpected Shutdown 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 225 225
No Consequences Or Impact To Patient 38 38
No Patient Involvement 12 12
Cardiac Arrest 4 4
Bradycardia 2 2
Atrial Fibrillation 1 1
Non specific EKG/ECG Changes 1 1

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