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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
2017 654 654
2018 955 955
2019 1001 1001
2020 1092 1092
2021 899 899
2022 275 275

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 1950 1950
Mechanical Problem 683 683
No Display/Image 443 443
Calibration Problem 341 341
Display or Visual Feedback Problem 321 321
Break 263 263
Output Problem 230 230
Failure to Power Up 184 184
Use of Device Problem 152 152
Component Missing 139 139
Unexpected Shutdown 126 126
No Device Output 125 125
Device Sensing Problem 122 122
Electrical /Electronic Property Problem 117 117
Device Displays Incorrect Message 113 113
Material Integrity Problem 106 106
Battery Problem 73 73
Corroded 63 63
Power Problem 63 63
Loose or Intermittent Connection 58 58
Failure to Capture 56 56
Contamination 48 48
Crack 34 34
Failure to Sense 32 32
Insufficient Information 30 30
Under-Sensing 28 28
Device Operates Differently Than Expected 27 27
Nonstandard Device 25 25
Pacing Intermittently 24 24
Moisture Damage 23 23
Capturing Problem 23 23
Pacing Problem 21 21
Device Difficult to Program or Calibrate 19 19
Intermittent Capture 18 18
Inadequate User Interface 18 18
Computer Software Problem 17 17
Degraded 13 13
Output below Specifications 12 12
Failure to Shut Off 11 11
Difficult to Insert 11 11
Blocked Connection 11 11
Contamination /Decontamination Problem 10 10
Output above Specifications 10 10
Operating System Becomes Nonfunctional 10 10
Data Problem 8 8
Device Contamination with Chemical or Other Material 8 8
No Pacing 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Signal Artifact/Noise 7 7
Over-Sensing 6 6
Noise, Audible 6 6
Appropriate Term/Code Not Available 5 5
Electronic Property Issue 5 5
Defective Device 5 5
Failure to Calibrate 5 5
Sensing Intermittently 4 4
Detachment of Device or Device Component 4 4
Failure of Device to Self-Test 3 3
Impedance Problem 3 3
Physical Resistance/Sticking 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Failure to Read Input Signal 3 3
Defective Component 3 3
Misfire 3 3
Display Difficult to Read 3 3
Premature Discharge of Battery 2 2
Circuit Failure 2 2
Device Emits Odor 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Communication or Transmission Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Intermittent Loss of Power 2 2
Patient Device Interaction Problem 2 2
Mechanical Jam 2 2
Inappropriate or Unexpected Reset 2 2
Device Dislodged or Dislocated 2 2
Electrical Power Problem 1 1
Device Operational Issue 1 1
Material Protrusion/Extrusion 1 1
Inadequate Lighting 1 1
Operating System Version or Upgrade Problem 1 1
Scratched Material 1 1
Component Misassembled 1 1
Device Handling Problem 1 1
Incomplete or Inadequate Connection 1 1
Key or Button Unresponsive/not Working 1 1
Material Perforation 1 1
Device Inoperable 1 1
Cut In Material 1 1
Structural Problem 1 1
Failure to Align 1 1
Device Slipped 1 1
Sticking 1 1
Material Separation 1 1
Product Quality Problem 1 1
Computer Operating System Problem 1 1
Increased Sensitivity 1 1
Inappropriate Waveform 1 1
Low Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2620 2620
No Clinical Signs, Symptoms or Conditions 1381 1381
No Known Impact Or Consequence To Patient 771 771
No Consequences Or Impact To Patient 102 102
Cardiac Arrest 43 43
Ventricular Fibrillation 23 23
Ventricular Tachycardia 15 15
Arrhythmia 15 15
Bradycardia 14 14
R On T Phenomenon 9 9
Tachycardia 8 8
Loss of consciousness 6 6
Death 6 6
No Information 5 5
No Code Available 5 5
Asystole 3 3
Heart Block 3 3
Cardiopulmonary Arrest 3 3
Erythema 3 3
Injury 3 3
Sudden Cardiac Death 2 2
Burn, Thermal 2 2
Non specific EKG/ECG Changes 2 2
Low Blood Pressure/ Hypotension 2 2
Syncope 2 2
Abrasion 2 2
Complete Heart Block 2 2
Skin Inflammation/ Irritation 2 2
Unspecified Heart Problem 1 1
Blister 1 1
Ectopic Heartbeat 1 1
Syncope/Fainting 1 1
Chest Pain 1 1
Dyspnea 1 1
Hypoxia 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Skin Discoloration 1 1
Electro-Mechanical Dissociation 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Loss Of Pulse 1 1
Diminished Pulse Pressure 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sweating 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Muscle Stimulation 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Torsades-de-Pointes 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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