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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse-generator, pacemaker, external
Product CodeDTE
Regulation Number 870.3600
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 955 955
2019 1001 1001
2020 1092 1092
2021 899 899
2022 834 834
2023 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 1737 1737
Mechanical Problem 715 715
No Display/Image 517 517
Display or Visual Feedback Problem 395 395
Calibration Problem 385 385
Break 269 269
Output Problem 244 244
Failure to Power Up 217 217
Use of Device Problem 191 191
Unexpected Shutdown 164 164
Device Sensing Problem 147 147
No Device Output 132 132
Component Missing 125 125
Material Integrity Problem 123 123
Electrical /Electronic Property Problem 119 119
Corroded 100 100
Battery Problem 79 79
Failure to Capture 63 63
Loose or Intermittent Connection 62 62
Device Displays Incorrect Message 61 61
Contamination 59 59
Power Problem 51 51
Crack 37 37
Capturing Problem 33 33
Failure to Sense 30 30
Insufficient Information 30 30
Nonstandard Device 25 25
Moisture Damage 24 24
Pacing Problem 24 24
Pacing Intermittently 24 24
Under-Sensing 20 20
Inadequate User Interface 20 20
Intermittent Capture 18 18
Computer Software Problem 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Device Difficult to Program or Calibrate 14 14
Output below Specifications 13 13
Device Operates Differently Than Expected 12 12
Contamination /Decontamination Problem 11 11
Blocked Connection 11 11
Difficult to Insert 10 10
Failure to Shut Off 10 10
Output above Specifications 9 9
Signal Artifact/Noise 8 8
Over-Sensing 7 7
Data Problem 7 7
Operating System Becomes Nonfunctional 7 7
No Pacing 6 6
Failure to Calibrate 6 6
Defective Device 5 5
Circuit Failure 5 5
Degraded 5 5
Noise, Audible 5 5
Device Contamination with Chemical or Other Material 5 5
Failure of Device to Self-Test 4 4
Appropriate Term/Code Not Available 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Detachment of Device or Device Component 4 4
Defective Component 3 3
Misfire 3 3
Sensing Intermittently 3 3
Failure to Read Input Signal 3 3
Display Difficult to Read 3 3
Physical Resistance/Sticking 3 3
Electronic Property Issue 3 3
Inappropriate or Unexpected Reset 2 2
Impedance Problem 2 2
Mechanical Jam 2 2
Intermittent Loss of Power 2 2
Key or Button Unresponsive/not Working 2 2
Patient Device Interaction Problem 2 2
Material Discolored 2 2
Device Emits Odor 2 2
Improper or Incorrect Procedure or Method 2 2
Deformation Due to Compressive Stress 2 2
Patient-Device Incompatibility 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 1 1
Sparking 1 1
Inappropriate Waveform 1 1
Material Perforation 1 1
Incomplete or Missing Packaging 1 1
Cut In Material 1 1
Structural Problem 1 1
Failure to Align 1 1
Sticking 1 1
Product Quality Problem 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Energy Output Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Fracture 1 1
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Disconnection 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Electromagnetic Interference 1 1
Arcing at Paddles 1 1
Premature Discharge of Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2168 2168
No Clinical Signs, Symptoms or Conditions 2021 2021
No Known Impact Or Consequence To Patient 600 600
No Consequences Or Impact To Patient 100 100
Cardiac Arrest 46 46
Arrhythmia 24 24
Ventricular Fibrillation 20 20
Tachycardia 14 14
Bradycardia 11 11
Loss of consciousness 7 7
Ventricular Tachycardia 7 7
Asystole 7 7
No Code Available 5 5
R On T Phenomenon 4 4
No Information 4 4
Heart Block 4 4
Death 4 4
Non specific EKG/ECG Changes 3 3
Low Blood Pressure/ Hypotension 3 3
Erythema 3 3
Injury 3 3
Skin Inflammation/ Irritation 2 2
Burn, Thermal 2 2
Pneumonia 2 2
Hypoxia 2 2
Cardiopulmonary Arrest 2 2
Syncope 2 2
Abrasion 2 2
Aspiration/Inhalation 1 1
Chest Pain 1 1
Muscle Stimulation 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Perforation 1 1
Electro-Mechanical Dissociation 1 1
Dyspnea 1 1
Sepsis 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Torsades-de-Pointes 1 1
Sweating 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Loss Of Pulse 1 1
Complete Heart Block 1 1
Superficial (First Degree) Burn 1 1
Discomfort 1 1
Unspecified Heart Problem 1 1
Blister 1 1
Ectopic Heartbeat 1 1
Pericardial Effusion 1 1
Syncope/Fainting 1 1
Drug Resistant Bacterial Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Detek, Inc. II Jul-03-2019
2 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-29-2018
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