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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 1683 1683

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 1427 1427
No Display/Image 1016 1016
Computer Operating System Problem 787 787
Output Problem 709 709
Failure to Calibrate 621 621
Computer Software Problem 521 521
Device Operates Differently Than Expected 458 458
Communication or Transmission Problem 422 422
Electrical /Electronic Property Problem 345 345
Power Problem 324 324
Inadequate User Interface 316 316
Unexpected Shutdown 302 302
Mechanical Problem 269 269
Overheating of Device 264 264
Failure to Power Up 226 226
Connection Problem 226 226
Problem with Software Installation 214 214
Data Problem 166 166
Display or Visual Feedback Problem 160 160
Failure to Interrogate 145 145
Incorrect Measurement 142 142
Noise, Audible 134 134
Material Integrity Problem 133 133
Break 128 128
Signal Artifact/Noise 124 124
Use of Device Problem 121 121
Loose or Intermittent Connection 99 99
Operating System Becomes Nonfunctional 95 95
Device Sensing Problem 79 79
Adverse Event Without Identified Device or Use Problem 74 74
Crack 64 64
Calibration Problem 63 63
Application Interface Becomes Non-Functional Or Program Exits Abnormally 55 55
Device Displays Incorrect Message 52 52
High impedance 51 51
Over-Sensing 50 50
Corroded 48 48
Battery Problem 48 48
Interrogation Problem 45 45
Ambient Noise Problem 41 41
Device Emits Odor 36 36
Contamination 35 35
Application Program Freezes, Becomes Nonfunctional 33 33
No Device Output 33 33
Degraded 29 29
Improper Device Output 29 29
Inappropriate/Inadequate Shock/Stimulation 28 28
Impedance Problem 27 27
Insufficient Information 27 27
Failure to Sense 26 26
Thermal Decomposition of Device 26 26
Electrical Shorting 25 25
Capturing Problem 20 20
Component Missing 18 18
Appropriate Term/Code Not Available 18 18
Failure to Capture 16 16
Device Contamination with Chemical or Other Material 15 15
Under-Sensing 13 13
Loss of Power 12 12
Low impedance 12 12
Premature Discharge of Battery 12 12
Erratic or Intermittent Display 11 11
Pacing Problem 11 11
Failure to Shut Off 11 11
Device Operational Issue 10 10
Application Program Problem 10 10
Incorrect Software Programming Calculations 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Contamination /Decontamination Problem 9 9
Issue With Displayed Error Message 8 8
Cut In Material 8 8
Sparking 8 8
Wireless Communication Problem 7 7
Screen 7 7
Device Alarm System 6 6
Device Programmer 6 6
Display Difficult to Read 6 6
Incorrect Or Inadequate Test Results 6 6
Structural Problem 6 6
Smoking 6 6
Telemetry Discrepancy 6 6
Application Program Version or Upgrade Problem 6 6
No Audible Alarm 6 6
Electromagnetic Interference 6 6
Blocked Connection 5 5
Date/Time-Related Software Problem 5 5
Defective Device 5 5
Material Perforation 5 5
Electrical Power Problem 5 5
No Pacing 5 5
Intermittent Communication Failure 4 4
Defibrillation/Stimulation Problem 4 4
Output above Specifications 4 4
Imprecision 4 4
Moisture Damage 4 4
Failure to Align 4 4
Operating System Version or Upgrade Problem 4 4
Material Twisted/Bent 4 4
Bent 4 4
Therapeutic or Diagnostic Output Failure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3408 3408
No Patient Involvement 2991 2991
No Consequences Or Impact To Patient 640 640
No Clinical Signs, Symptoms or Conditions 347 347
No Information 98 98
Cardiac Arrest 19 19
Unspecified Infection 19 19
Electric Shock 13 13
Dizziness 10 10
Syncope 10 10
Death 9 9
Ventricular Tachycardia 8 8
Shock 4 4
No Code Available 4 4
Ventricular Fibrillation 4 4
Injury 3 3
Atrial Fibrillation 3 3
Pocket Erosion 3 3
Seizures 3 3
Sepsis 3 3
Endocarditis 2 2
Cardiopulmonary Arrest 2 2
Staphylococcus Aureus 2 2
Shock from Patient Lead(s) 2 2
Arrhythmia 2 2
Tachycardia 2 2
Discomfort 2 2
Complaint, Ill-Defined 1 1
Shaking/Tremors 1 1
Loss Of Pulse 1 1
Not Applicable 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Edema 1 1
Electrocution 1 1
Hemorrhage/Bleeding 1 1
Muscular Rigidity 1 1
Heart Failure 1 1
Convulsion, Clonic 1 1
Infection, Indirect 1 1
Toxoplasmosis, Acquired 1 1
Pregnancy 1 1
Insufficient Information 1 1
Vascular Dissection 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

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