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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 231 231

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 1390 1390
Mechanical Problem 690 690
No Display/Image 584 584
Display or Visual Feedback Problem 430 430
Calibration Problem 414 414
Output Problem 285 285
Failure to Power Up 238 238
Break 225 225
Use of Device Problem 207 207
Device Sensing Problem 207 207
Unexpected Shutdown 199 199
No Device Output 172 172
Material Integrity Problem 137 137
Corroded 126 126
Component Missing 125 125
Electrical /Electronic Property Problem 94 94
Battery Problem 86 86
Contamination 83 83
Failure to Capture 68 68
Loose or Intermittent Connection 58 58
Crack 44 44
Capturing Problem 40 40
Power Problem 38 38
Insufficient Information 29 29
Pacing Intermittently 25 25
Failure to Sense 25 25
Moisture Damage 23 23
Pacing Problem 19 19
Under-Sensing 16 16
Inadequate User Interface 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Intermittent Capture 14 14
Failure to Shut Off 13 13
Contamination /Decontamination Problem 13 13
Output below Specifications 11 11
Blocked Connection 9 9
Operating System Becomes Nonfunctional 8 8
Output above Specifications 8 8
Difficult to Insert 8 8
Device Difficult to Program or Calibrate 8 8
Failure to Calibrate 7 7
Sensing Intermittently 6 6
Data Problem 6 6
No Pacing 5 5
Noise, Audible 5 5
Over-Sensing 5 5
Circuit Failure 5 5
Failure of Device to Self-Test 4 4
Device Contamination with Chemical or Other Material 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Misfire 3 3
Defective Device 3 3
Computer Software Problem 3 3
Display Difficult to Read 3 3
Device Emits Odor 2 2
Defibrillation/Stimulation Problem 2 2
Signal Artifact/Noise 2 2
Communication or Transmission Problem 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Impedance Problem 2 2
Mechanical Jam 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
Key or Button Unresponsive/not Working 2 2
High Capture Threshold 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Split, Cut or Torn 1 1
Incomplete or Inadequate Connection 1 1
Human-Device Interface Problem 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Incomplete or Missing Packaging 1 1
Sparking 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 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
Loss of Power 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2760 2760
No Patient Involvement 1430 1430
No Known Impact Or Consequence To Patient 388 388
No Consequences Or Impact To Patient 98 98
Cardiac Arrest 45 45
Arrhythmia 26 26
Ventricular Fibrillation 25 25
Tachycardia 19 19
Bradycardia 13 13
Asystole 13 13
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 4 4
Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Non specific EKG/ECG Changes 3 3
Erythema 3 3
Low Blood Pressure/ Hypotension 3 3
Cardiopulmonary Arrest 2 2
Death 2 2
Abrasion 2 2
Pneumonia 2 2
Low Oxygen Saturation 2 2
Burn, Thermal 2 2
Pericardial Effusion 2 2
Blister 2 2
Skin Inflammation/ Irritation 2 2
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1
Ectopic Heartbeat 1 1
Syncope/Fainting 1 1
Complete Heart Block 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
Cardiac Tamponade 1 1
Discomfort 1 1
Sepsis 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Dizziness 1 1
Dyspnea 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Aspiration/Inhalation 1 1
Atrial Flutter 1 1
Hypoxia 1 1
Memory Loss/Impairment 1 1
Device Overstimulation of Tissue 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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