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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

MDR Year MDR Reports MDR Events
2016 1886 1886
2017 1407 1407
2018 1326 1326
2019 1175 1175
2020 1689 1689
2021 968 968

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 1662 1662
No Display/Image 1186 1186
Output Problem 1002 1002
Computer Operating System Problem 881 881
Failure to Calibrate 686 686
Computer Software Problem 579 579
Device Operates Differently Than Expected 458 458
Communication or Transmission Problem 452 452
Electrical /Electronic Property Problem 383 383
Unexpected Shutdown 371 371
Power Problem 344 344
Inadequate User Interface 322 322
Mechanical Problem 309 309
Overheating of Device 291 291
Failure to Power Up 258 258
Connection Problem 243 243
Problem with Software Installation 239 239
Display or Visual Feedback Problem 221 221
Data Problem 181 181
Use of Device Problem 156 156
Failure to Interrogate 155 155
Material Integrity Problem 147 147
Noise, Audible 147 147
Break 145 145
Incorrect Measurement 143 143
Signal Artifact/Noise 126 126
Loose or Intermittent Connection 106 106
Operating System Becomes Nonfunctional 102 102
Device Sensing Problem 84 84
Adverse Event Without Identified Device or Use Problem 75 75
Crack 75 75
Calibration Problem 63 63
Corroded 62 62
Battery Problem 57 57
Application Interface Becomes Non-Functional Or Program Exits Abnormally 55 55
Device Displays Incorrect Message 53 53
High impedance 51 51
Over-Sensing 51 51
Interrogation Problem 51 51
Ambient Noise Problem 41 41
Device Emits Odor 37 37
Contamination 36 36
Application Program Freezes, Becomes Nonfunctional 35 35
No Device Output 33 33
Degraded 29 29
Electrical Shorting 29 29
Improper Device Output 29 29
Impedance Problem 28 28
Inappropriate/Inadequate Shock/Stimulation 28 28
Insufficient Information 28 28
Failure to Sense 26 26
Thermal Decomposition of Device 26 26
Capturing Problem 22 22
Component Missing 18 18
Appropriate Term/Code Not Available 18 18
Failure to Capture 17 17
Under-Sensing 15 15
Device Contamination with Chemical or Other Material 15 15
Premature Discharge of Battery 14 14
Failure to Shut Off 13 13
Application Program Problem 12 12
Low impedance 12 12
Erratic or Intermittent Display 12 12
Loss of Power 12 12
Pacing Problem 12 12
Incorrect, Inadequate or Imprecise Resultor Readings 11 11
Incorrect Software Programming Calculations 10 10
Contamination /Decontamination Problem 10 10
Device Operational Issue 10 10
Cut In Material 8 8
Sparking 8 8
Date/Time-Related Software Problem 8 8
Issue With Displayed Error Message 8 8
Application Program Version or Upgrade Problem 7 7
Defective Device 7 7
Wireless Communication Problem 7 7
Incorrect Or Inadequate Test Results 6 6
Structural Problem 6 6
Material Twisted/Bent 6 6
Smoking 6 6
Telemetry Discrepancy 6 6
Electromagnetic Interference 6 6
Moisture Damage 6 6
Device Alarm System 6 6
No Audible Alarm 6 6
Display Difficult to Read 6 6
Electrical Power Problem 5 5
Defective Component 5 5
Material Perforation 5 5
Blocked Connection 5 5
No Pacing 5 5
Delayed Program or Algorithm Execution 4 4
Intermittent Communication Failure 4 4
Defibrillation/Stimulation Problem 4 4
Failure to Align 4 4
Operating System Version or Upgrade Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Bent 4 4
Nonstandard Device 4 4
Imprecision 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3414 3414
No Patient Involvement 2996 2996
No Clinical Signs, Symptoms or Conditions 1344 1344
No Consequences Or Impact To Patient 645 645
No Information 101 101
Cardiac Arrest 20 20
Unspecified Infection 20 20
Electric Shock 13 13
Dizziness 10 10
Syncope 10 10
Death 9 9
Ventricular Tachycardia 9 9
No Code Available 6 6
Shock 5 5
Ventricular Fibrillation 4 4
Tachycardia 3 3
Injury 3 3
Arrhythmia 3 3
Atrial Fibrillation 3 3
Pocket Erosion 3 3
Seizures 3 3
Sepsis 3 3
Insufficient Information 3 3
Shock from Patient Lead(s) 2 2
Endocarditis 2 2
Cardiopulmonary Arrest 2 2
Staphylococcus Aureus 2 2
Discomfort 2 2
Complaint, Ill-Defined 1 1
Shaking/Tremors 1 1
Loss Of Pulse 1 1
Asystole 1 1
Not Applicable 1 1
Muscular Rigidity 1 1
Heart Failure 1 1
Convulsion, Clonic 1 1
Infection, Indirect 1 1
Toxoplasmosis, Acquired 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Edema 1 1
Electrocution 1 1
Hemorrhage/Bleeding 1 1
Erosion 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Fainting 1 1
Fall 1 1
Fever 1 1
Failure of Implant 1 1
Renal Failure 1 1
Swelling 1 1
Perforation of Vessels 1 1
Malaise 1 1
Coma 1 1
Loss of consciousness 1 1
Sudden Cardiac Death 1 2
Pregnancy 1 1
Vascular Dissection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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