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

MDR Year MDR Reports MDR Events
2019 1001 1001
2020 1092 1092
2021 899 899
2022 833 833
2023 650 650
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 1372 1372
Mechanical Problem 658 658
No Display/Image 567 567
Display or Visual Feedback Problem 418 418
Calibration Problem 401 401
Output Problem 265 265
Failure to Power Up 231 231
Break 216 216
Use of Device Problem 200 200
Unexpected Shutdown 189 189
Device Sensing Problem 181 181
No Device Output 153 153
Material Integrity Problem 134 134
Corroded 124 124
Component Missing 123 123
Electrical /Electronic Property Problem 86 86
Battery Problem 85 85
Contamination 77 77
Failure to Capture 66 66
Loose or Intermittent Connection 58 58
Crack 39 39
Capturing Problem 39 39
Power Problem 37 37
Insufficient Information 29 29
Failure to Sense 24 24
Pacing Intermittently 23 23
Moisture Damage 22 22
Pacing Problem 18 18
Under-Sensing 16 16
Inadequate User Interface 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Intermittent Capture 14 14
Failure to Shut Off 12 12
Contamination /Decontamination Problem 12 12
Output below Specifications 11 11
Blocked Connection 9 9
Output above Specifications 8 8
Device Difficult to Program or Calibrate 8 8
Difficult to Insert 8 8
Failure to Calibrate 7 7
Operating System Becomes Nonfunctional 7 7
Data Problem 6 6
No Pacing 5 5
Noise, Audible 5 5
Over-Sensing 5 5
Circuit Failure 5 5
Sensing Intermittently 4 4
Device Contamination with Chemical or Other Material 4 4
Failure of Device to Self-Test 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Misfire 3 3
Defective Device 3 3
Display Difficult to Read 3 3
Computer Software Problem 3 3
Signal Artifact/Noise 2 2
Device Emits Odor 2 2
Defibrillation/Stimulation Problem 2 2
Defective Component 2 2
Communication or Transmission Problem 2 2
Patient-Device Incompatibility 2 2
Impedance Problem 2 2
Mechanical Jam 2 2
Key or Button Unresponsive/not Working 2 2
Physical Resistance/Sticking 2 2
Intermittent Loss of Power 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 1 1
High Capture Threshold 1 1
Incomplete or Inadequate Connection 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Human-Device Interface Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Deformation Due to Compressive Stress 1 1
Incomplete or Missing Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Sparking 1 1
Loss of Power 1 1
Labelling, Instructions for Use or Training Problem 1 1
Premature Discharge of Battery 1 1
Arcing at Paddles 1 1
Degraded 1 1
Material Discolored 1 1
Disconnection 1 1
Fracture 1 1
Electromagnetic Interference 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2582 2582
No Patient Involvement 1430 1430
No Known Impact Or Consequence To Patient 388 388
No Consequences Or Impact To Patient 98 98
Cardiac Arrest 41 41
Arrhythmia 24 24
Ventricular Fibrillation 24 24
Tachycardia 16 16
Asystole 13 13
Bradycardia 12 12
Loss of consciousness 9 9
Ventricular Tachycardia 5 5
Heart Block 4 4
R On T Phenomenon 4 4
No Information 4 4
No Code Available 4 4
Superficial (First Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Injury 3 3
Non specific EKG/ECG Changes 3 3
Erythema 3 3
Low Blood Pressure/ Hypotension 3 3
Abrasion 2 2
Cardiopulmonary Arrest 2 2
Death 2 2
Low Oxygen Saturation 2 2
Pneumonia 2 2
Skin Inflammation/ Irritation 2 2
Burn, Thermal 2 2
Pericardial Effusion 2 2
Syncope/Fainting 1 1
Complete Heart Block 1 1
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1
Unspecified Heart Problem 1 1
Blister 1 1
Ectopic Heartbeat 1 1
Sepsis 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Dizziness 1 1
Cardiac Tamponade 1 1
Discomfort 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Cardiac Perforation 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sweating 1 1
Diaphoresis 1 1
Dyspnea 1 1
Chest Pain 1 1
Aspiration/Inhalation 1 1
Atrial Flutter 1 1
Hypoxia 1 1
Memory Loss/Impairment 1 1
Perforation 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Detek, Inc. II Jul-03-2019
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