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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 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
OSYPKA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 67 67
2015 342 342
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 2453 2453
Mechanical Problem 985 985
No Display/Image 725 725
Calibration Problem 496 496
Display or Visual Feedback Problem 454 454
Output Problem 403 403
Break 350 350
Failure to Power Up 303 303
Device Sensing Problem 248 248
Device Displays Incorrect Message 244 244
No Device Output 240 240
Use of Device Problem 210 210
Nonstandard Device 204 204
Unexpected Shutdown 203 203
Component Missing 183 183
Electrical /Electronic Property Problem 178 178
Material Integrity Problem 157 157
Corroded 138 138
Contamination 102 102
Battery Problem 100 100
Power Problem 97 97
Failure to Capture 87 87
Loose or Intermittent Connection 83 83
Device Operates Differently Than Expected 63 63
Crack 62 62
Failure to Sense 52 52
Capturing Problem 49 49
Under-Sensing 41 41
Pacing Problem 37 37
Moisture Damage 35 35
Pacing Intermittently 34 34
Insufficient Information 33 33
Computer Software Problem 31 31
Inadequate User Interface 25 25
Device Difficult to Program or Calibrate 23 23
Intermittent Capture 20 20
Failure of Device to Self-Test 18 18
Device Contamination with Chemical or Other Material 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Failure to Shut Off 16 16
Output below Specifications 16 16
Degraded 16 16
Over-Sensing 13 13
Difficult to Insert 13 13
Operating System Becomes Nonfunctional 13 13
Blocked Connection 13 13
Contamination /Decontamination Problem 12 12
Output above Specifications 11 11
Signal Artifact/Noise 10 10
No Pacing 9 9
Data Problem 9 9
Appropriate Term/Code Not Available 7 7
Failure to Calibrate 7 7
Loss of Power 6 6
Noise, Audible 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Defective Device 5 5
Impedance Problem 5 5
Computer Operating System Problem 5 5
Electronic Property Issue 5 5
Sensing Intermittently 5 5
Circuit Failure 5 5
Premature Discharge of Battery 4 4
Display Difficult to Read 4 4
Improper or Incorrect Procedure or Method 4 4
Defective Component 4 4
Detachment of Device or Device Component 4 4
Device Dislodged or Dislocated 3 3
Communication or Transmission Problem 3 3
Human-Device Interface Problem 3 3
Physical Resistance/Sticking 3 3
Device Inoperable 3 3
Misfire 3 3
Low Battery 3 3
Failure to Read Input Signal 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Detachment Of Device Component 2 2
Material Discolored 2 2
Disconnection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Device Emits Odor 2 2
Defibrillation/Stimulation Problem 2 2
Intermittent Loss of Power 2 2
Key or Button Unresponsive/not Working 2 2
Patient Device Interaction Problem 2 2
Inappropriate or Unexpected Reset 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Device Damaged by Another Device 2 2
Device Packaging Compromised 1 1
Electrical Power Problem 1 1
Device Operational Issue 1 1
Moisture or Humidity Problem 1 1
Compatibility Problem 1 1
Issue With Displayed Error Message 1 1
Material Distortion 1 1
Improper Device Output 1 1
Inadequate Lighting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3169 3169
No Clinical Signs, Symptoms or Conditions 2705 2705
No Known Impact Or Consequence To Patient 1095 1095
No Consequences Or Impact To Patient 103 103
Cardiac Arrest 70 70
Ventricular Fibrillation 36 36
Arrhythmia 28 28
Ventricular Tachycardia 20 20
Tachycardia 20 20
Bradycardia 19 19
Asystole 13 13
R On T Phenomenon 11 11
Loss of consciousness 11 11
Death 8 8
No Information 7 7
No Code Available 5 5
Complete Heart Block 5 5
Superficial (First Degree) Burn 4 4
Heart Block 4 4
Injury 3 3
Low Oxygen Saturation 3 3
Cardiopulmonary Arrest 3 3
Chest Pain 3 3
Non specific EKG/ECG Changes 3 3
Erythema 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hypoxia 2 2
Pneumonia 2 2
Seizures 2 2
Shock 2 2
Electro-Mechanical Dissociation 2 2
Syncope 2 2
Abrasion 2 2
Cardiogenic Shock 2 2
Sudden Cardiac Death 2 2
Burn, Thermal 2 2
Loss Of Pulse 2 2
Pericardial Effusion 2 2
Skin Inflammation/ Irritation 2 2
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1
Ectopic Heartbeat 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1
Blister 1 1
Syncope/Fainting 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Cardiac Perforation 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Discomfort 1 1
Cardiac Tamponade 1 1
Respiratory Failure 1 1
Sweating 1 1
Diaphoresis 1 1
Muscle Stimulation 1 1
Aspiration/Inhalation 1 1
Atrial Fibrillation 1 1
Atrial Flutter 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Dyspnea 1 1
Skin Discoloration 1 1
Torsades-de-Pointes 1 1
Dizziness 1 1
Ventricular Flutter 1 1
Sepsis 1 1
Septic Shock 1 1
Renal Failure 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

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Detek, Inc. II Jul-03-2019
2 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-31-2015
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-29-2018
4 Osypka Medical Inc II Sep-21-2010
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