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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
  1.  K170815  PSA Cable
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 106 106

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 121 121
Communication or Transmission Problem 78 78
Display or Visual Feedback Problem 50 50
Computer Operating System Problem 48 48
Device Difficult to Program or Calibrate 23 23
Device Sensing Problem 23 23
Pacing Problem 21 21
Output Problem 21 21
Data Problem 16 16
Device Displays Incorrect Message 15 15
Failure to Capture 8 8
Impedance Problem 7 7
Capturing Problem 6 6
Inadequate User Interface 5 5
High impedance 5 5
Under-Sensing 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Unexpected Shutdown 3 3
Appropriate Term/Code Not Available 2 2
Application Program Problem 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
Signal Artifact/Noise 1 1
Failure to Sense 1 1
Mechanical Problem 1 1
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

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 57 57
No Patient Involvement 14 14
Cardiac Arrest 4 4
Bradycardia 2 2
Atrial Fibrillation 1 1
Non specific EKG/ECG Changes 1 1

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