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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)
2015 2016 2017 2018 2019 2020
2 0 0 0 0 0

MDR Year MDR Reports MDR Events
2015 3244 3244
2016 1886 1886
2017 1407 1407
2018 1327 1327
2019 1175 1175
2020 888 888

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 1534 1534
No Display/Image 1145 1145
Computer Operating System Problem 1088 1088
Communication or Transmission Problem 1040 1040
Computer Software Problem 756 756
Electrical /Electronic Property Problem 723 723
Failure to Calibrate 611 611
Device Operates Differently Than Expected 572 572
Output Problem 442 442
Inadequate User Interface 420 420
Power Problem 402 402
Mechanical Problem 390 390
Connection Problem 371 371
Failure to Power Up 343 343
Overheating of Device 282 282
Unexpected Shutdown 257 257
Problem with Software Installation 236 236
Loose or Intermittent Connection 215 215
Break 198 198
Failure to Interrogate 191 191
Noise, Audible 182 182
Data Problem 178 178
Signal Artifact/Noise 162 162
Operating System Becomes Nonfunctional 152 152
Material Integrity Problem 149 149
Incorrect Measurement 144 144
Display or Visual Feedback Problem 137 137
Adverse Event Without Identified Device or Use Problem 118 118
Degraded 103 103
Use of Device Problem 97 97
Device Sensing Problem 93 93
Crack 83 83
Device Displays Incorrect Message 80 80
High impedance 79 79
Application Interface Becomes Non-Functional Or Program Exits Abnormally 76 76
Corroded 69 69
Calibration Problem 63 63
Over-Sensing 57 57
Battery Problem 53 53
No Device Output 47 47
Device Emits Odor 43 43
Insufficient Information 43 43
Ambient Noise Problem 43 43
Inappropriate/Inadequate Shock/Stimulation 39 39
Contamination 38 38
Interrogation Problem 37 37
Thermal Decomposition of Device 35 35
Impedance Problem 34 34
Improper Device Output 33 33
Failure to Sense 32 32
Application Program Freezes, Becomes Nonfunctional 31 31
Cut In Material 29 29
Component Missing 29 29
Capturing Problem 26 26
Failure to Capture 25 25
Electrical Shorting 24 24
Appropriate Term/Code Not Available 24 24
Hole In Material 23 23
Device Contamination with Chemical or Other Material 20 20
Premature Discharge of Battery 19 19
Pacing Problem 19 19
Low impedance 16 16
Loss of Power 16 16
Issue With Displayed Error Message 15 15
Erratic or Intermittent Display 14 14
Application Program Problem 14 14
Application Program Version or Upgrade Problem 14 14
Under-Sensing 14 14
Device Component Or Accessory 11 11
Failure to Shut Off 11 11
Device Operational Issue 10 10
Sparking 10 10
Incorrect Software Programming Calculations 10 10
Smoking 10 10
Screen 10 10
Material Rupture 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Telemetry Discrepancy 8 8
No Audible Alarm 8 8
Wireless Communication Problem 8 8
Contamination /Decontamination Problem 8 8
Material Frayed 8 8
Device Alarm System 7 7
Device Programmer 7 7
Torn Material 7 7
Material Perforation 7 7
Incorrect Or Inadequate Test Results 7 7
Structural Problem 6 6
Defective Device 6 6
Electromagnetic Interference 6 6
Programming Issue 6 6
Device Damaged by Another Device 6 6
Operating System Version or Upgrade Problem 6 6
Display Difficult to Read 6 6
Loss of Data 6 6
Defibrillation/Stimulation Problem 6 6
Electrical Power Problem 6 6
No Pacing 5 5
Failure to Disconnect 5 5
Bent 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5132 5132
No Patient Involvement 4127 4127
No Consequences Or Impact To Patient 437 437
No Information 105 105
Unspecified Infection 26 26
Cardiac Arrest 25 25
Electric Shock 16 16
Syncope 14 14
Death 10 10
Dizziness 10 10
Ventricular Tachycardia 10 10
No Code Available 8 8
Shock 8 8
Ventricular Fibrillation 6 6
Pocket Erosion 5 5
Sepsis 5 5
Staphylococcus Aureus 4 4
Atrial Fibrillation 4 4
Not Applicable 4 4
Discomfort 3 3
Complaint, Ill-Defined 3 3
Injury 3 3
Arrhythmia 3 3
Seizures 3 3
Cardiopulmonary Arrest 3 3
Endocarditis 3 3
Fainting 2 2
Shock from Patient Lead(s) 2 2
Tachycardia 2 2
Weakness 1 1
Nausea 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Edema 1 1
Electrocution 1 1
Hemorrhage/Bleeding 1 1
Non-union Bone Fracture 1 1
Shaking/Tremors 1 1
Heart Failure 1 1
Convulsion, Clonic 1 1
Infection, Indirect 1 1
Toxoplasmosis, Acquired 1 1
Anxiety 1 1
Loss Of Pulse 1 1
Muscle Stimulation 1 1
Pregnancy 1 1
Vascular Dissection 1 1
Fall 1 1
Fatigue 1 1
Fever 1 1
Failure of Implant 1 1
Renal Failure 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Erosion 1 1
Cardiomyopathy 1 1
Swelling 1 1
Perforation of Vessels 1 1
Malaise 1 1
Coma 1 1
Palpitations 1 1
Sudden Cardiac Death 1 2

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