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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device programmer, pacemaker
Regulation Description Pacemaker programmers.
Product CodeKRG
Regulation Number 870.3700
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020
1 2 0 0 0 0 0

Device Problems
Device Difficult to Program or Calibrate 1110
No Display / Image 779
Computer Operating System Problem 609
Failure to Calibrate 481
Computer Software Problem 400
Device Operates Differently Than Expected 346
Power Problem 298
Inadequate User Interface 285
Communication or Transmission Problem 274
Output Problem 251
Electrical /Electronic Property Problem 230
Overheating of Device 217
Unexpected Shutdown 203
Mechanical Problem 196
Connection Problem 184
Problem with Software Installation 159
Failure to Power Up 156
Incorrect Measurement 132
Data Problem 132
Display or Visual Feedback Problem 111
Signal Artifact 109
Adverse Event Without Identified Device or Use Problem 107
Break 103
Noise, Audible 102
Failure to Interrogate 97
Material Integrity Problem 91
Operating System Becomes Nonfunctional 86
Use of Device Problem 72
Device Sensing Problem 68
High impedance 67
Application Interface Becomes Non-Functional Or Program Exits Abnormally 57
Loose or Intermittent Connection 57
Crack 53
Over-Sensing 49
Ambient Noise Problem 43
Corroded 39
Calibration Problem 38
Device Displays Incorrect Message 38
Battery Problem 34
Inappropriate Shock 31
Device Emits Odor 30
Contamination During Use 30
No Device Output 29
Impedance Problem 27
Interrogation Problem 23
Application Program Freezes, Becomes Nonfunctional 23
Electrical Shorting 21
Failure to Capture 19
Thermal Decomposition of Device 18
Capturing Problem 18
Failure to Sense 18
Insufficient Information 17
Low impedance 15
Degraded 15
Component Missing 14
Erratic or Intermittent Display 13
Pacing Problem 13
Premature Discharge of Battery 13
Device Contamination with Chemical or Other Material 12
Failure to Shut Off 11
Device Operational Issue 10
Under-Sensing 10
Programmer 10
Appropriate Term/Code Not Available 9
Issue With Displayed Error Message 8
Contamination / decontamination Problem 8
Telemetry Discrepancy 8
Device Alarm System 7
Wireless Communication Problem 7
No Audible Alarm 7
Display Difficult to Read 6
Incorrect Software Programming Calculations 6
Structural Problem 6
Sparking 6
Incorrect Or Inadequate Test Results 5
Blocked Connection 5
Defibrillation Problem 5
Electromagnetic Interference 5
Screen 4
Application Program Version or Upgrade Problem 4
Operating System Version or Upgrade Problem 4
Date/Time-Related Software Problem 4
Delayed Program or Algorithm Execution 4
No Pacing 4
Failure to Align 3
Difficult to Insert 3
Imprecision 3
No Apparent Adverse Event 3
Device Contamination With Biological Material 3
Bent 3
Incorrect, Inadequate or Imprecise Result or Readings 3
Intermittent Communication Failure 3
Smoking 3
Device Stops Intermittently 3
Electrical Power Problem 3
Packaging Problem 2
Programming Issue 2
Defective Device 2
Therapeutic or Diagnostic Output Failure 2
Failure to Read Input Signal 2
Total Device Problems 8468

Recalls
Manufacturer Recall Class Date Posted
1 Sorin Group USA, Inc. II Nov-15-2016

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