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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 6
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 496 496
2017 654 654
2018 956 956
2019 1001 1001
2020 1092 1092
2021 899 899
2022 833 833
2023 650 650
2024 171 171

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 2349 2349
Mechanical Problem 949 949
No Display/Image 703 703
Calibration Problem 493 493
Display or Visual Feedback Problem 454 454
Output Problem 380 380
Break 337 337
Failure to Power Up 284 284
Device Sensing Problem 238 238
No Device Output 229 229
Use of Device Problem 210 210
Unexpected Shutdown 203 203
Device Displays Incorrect Message 182 182
Component Missing 178 178
Electrical /Electronic Property Problem 165 165
Material Integrity Problem 155 155
Corroded 137 137
Contamination 101 101
Nonstandard Device 97 97
Battery Problem 94 94
Power Problem 85 85
Failure to Capture 83 83
Loose or Intermittent Connection 76 76
Crack 59 59
Failure to Sense 47 47
Capturing Problem 41 41
Device Operates Differently Than Expected 38 38
Under-Sensing 37 37
Moisture Damage 34 34
Pacing Problem 34 34
Pacing Intermittently 32 32
Insufficient Information 32 32
Inadequate User Interface 24 24
Device Difficult to Program or Calibrate 23 23
Intermittent Capture 20 20
Computer Software Problem 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Output below Specifications 16 16
Degraded 16 16
Failure to Shut Off 15 15
Device Contamination with Chemical or Other Material 14 14
Blocked Connection 13 13
Difficult to Insert 13 13
Over-Sensing 12 12
Contamination /Decontamination Problem 12 12
Operating System Becomes Nonfunctional 12 12
Output above Specifications 11 11
Signal Artifact/Noise 9 9
No Pacing 8 8
Data Problem 8 8
Failure to Calibrate 7 7
Noise, Audible 6 6
Appropriate Term/Code Not Available 6 6
Impedance Problem 5 5
Electronic Property Issue 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Defective Device 5 5
Sensing Intermittently 5 5
Circuit Failure 5 5
Display Difficult to Read 4 4
Improper or Incorrect Procedure or Method 4 4
Failure of Device to Self-Test 4 4
Detachment of Device or Device Component 4 4
Communication or Transmission Problem 3 3
Physical Resistance/Sticking 3 3
Device Inoperable 3 3
Failure to Read Input Signal 3 3
Misfire 3 3
Defective Component 3 3
Defibrillation/Stimulation Problem 2 2
Low Battery 2 2
Patient-Device Incompatibility 2 2
Material Discolored 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Premature Discharge of Battery 2 2
Device Emits Odor 2 2
Labelling, Instructions for Use or Training Problem 2 2
Intermittent Loss of Power 2 2
Patient Device Interaction Problem 2 2
Key or Button Unresponsive/not Working 2 2
Computer Operating System Problem 2 2
Deformation Due to Compressive Stress 2 2
Device Dislodged or Dislocated 2 2
Inappropriate or Unexpected Reset 2 2
Mechanical Jam 2 2
Moisture or Humidity Problem 1 1
Material Protrusion/Extrusion 1 1
Inadequate Lighting 1 1
Operating System Version or Upgrade Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Power Problem 1 1
Device Operational Issue 1 1
Human-Device Interface Problem 1 1
Incomplete or Inadequate Connection 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Handling Problem 1 1
High Capture Threshold 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2927 2927
No Clinical Signs, Symptoms or Conditions 2705 2705
No Known Impact Or Consequence To Patient 946 946
No Consequences Or Impact To Patient 102 102
Cardiac Arrest 60 60
Ventricular Fibrillation 33 33
Arrhythmia 28 28
Tachycardia 19 19
Ventricular Tachycardia 19 19
Bradycardia 17 17
Asystole 13 13
R On T Phenomenon 10 10
Loss of consciousness 9 9
No Information 7 7
Death 6 6
No Code Available 5 5
Superficial (First Degree) Burn 4 4
Heart Block 4 4
Complete Heart Block 4 4
Injury 3 3
Low Oxygen Saturation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Non specific EKG/ECG Changes 3 3
Low Blood Pressure/ Hypotension 3 3
Cardiopulmonary Arrest 3 3
Erythema 3 3
Shock 2 2
Pneumonia 2 2
Seizures 2 2
Syncope 2 2
Abrasion 2 2
Hypoxia 2 2
Skin Inflammation/ Irritation 2 2
Pericardial Effusion 2 2
Burn, Thermal 2 2
Loss Of Pulse 2 2
Sudden Cardiac Death 2 2
Cardiac Perforation 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sweating 1 1
Diaphoresis 1 1
Dizziness 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Respiratory Failure 1 1
Syncope/Fainting 1 1
Ectopic Heartbeat 1 1
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1
Blister 1 1
Memory Loss/Impairment 1 1
Mitral Regurgitation 1 1
Muscle Spasm(s) 1 1
Device Overstimulation of Tissue 1 1
Perforation 1 1
Electro-Mechanical Dissociation 1 1
Dyspnea 1 1
Aspiration/Inhalation 1 1
Atrial Flutter 1 1
Chest Pain 1 1
Muscle Stimulation 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
Ventricular Flutter 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Discomfort 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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