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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

Device Problems
Computer Software Problem 104
Communication or Transmission Problem 67
Display or Visual Feedback Problem 38
Computer Operating System Problem 36
Device Sensing Problem 21
Device Difficult to Program or Calibrate 20
Output Problem 20
Pacing Problem 17
Device Displays Incorrect Message 15
Data Problem 14
Failure to Capture 8
Impedance Problem 6
High impedance 5
Inadequate User Interface 5
Capturing Problem 4
Under-Sensing 4
Over-Sensing 2
Incorrect, Inadequate or Imprecise Resultor Readings 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2
Device Operational Issue 1
Wireless Communication Problem 1
Unable to Obtain Readings 1
Failure to Sense 1
Problem with Software Installation 1
Program or Algorithm Execution Problem 1
Signal Artifact/Noise 1
Application Program Problem 1
Power Problem 1
Mechanical Problem 1
Battery Problem 1
Unexpected Shutdown 1
Total Device Problems 402


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