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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device defibrillator, implantable, dual-chamber
Product CodeMRM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
20 23 18 9 20 8

MDR Year MDR Reports MDR Events
2019 345 345
2020 316 316
2021 575 575
2022 505 505
2023 557 557
2024 231 231

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 931 931
Adverse Event Without Identified Device or Use Problem 423 423
Premature End-of-Life Indicator 339 339
Over-Sensing 149 149
Battery Problem 115 115
Failure to Interrogate 112 112
Inappropriate/Inadequate Shock/Stimulation 94 94
High impedance 54 54
Premature Discharge of Battery 42 42
Display or Visual Feedback Problem 37 37
Low impedance 29 29
Communication or Transmission Problem 24 24
Insufficient Information 23 23
Data Problem 19 19
Inappropriate or Unexpected Reset 17 17
Device Displays Incorrect Message 16 16
Failure to Deliver Shock/Stimulation 16 16
Interrogation Problem 14 14
Application Program Freezes, Becomes Nonfunctional 14 14
Computer Software Problem 10 10
Pacemaker Found in Back-Up Mode 10 10
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Ambient Noise Problem 9 9
Device Sensing Problem 9 9
Appropriate Term/Code Not Available 8 8
Impedance Problem 8 8
No Pacing 8 8
Connection Problem 8 8
Migration or Expulsion of Device 8 8
Nonstandard Device 7 7
Fracture 7 7
Failure to Capture 7 7
Loss of Data 7 7
Unexpected Therapeutic Results 7 7
High Capture Threshold 7 7
Program or Algorithm Execution Problem 6 6
Defective Component 6 6
Delayed Charge Time 6 6
Signal Artifact/Noise 6 6
Electromagnetic Interference 6 6
Pacing Problem 6 6
Erratic or Intermittent Display 5 5
Application Program Problem 5 5
Device Markings/Labelling Problem 5 5
Under-Sensing 5 5
Defibrillation/Stimulation Problem 5 5
Wireless Communication Problem 5 5
Installation-Related Problem 5 5
Packaging Problem 4 4
Inaccurate Information 4 4
Unexpected Shutdown 4 4
Failure to Sense 4 4
Electrical /Electronic Property Problem 4 4
Mechanical Problem 4 4
Loose or Intermittent Connection 3 3
Failure to Convert Rhythm 3 3
Incorrect Interpretation of Signal 3 3
Intermittent Capture 3 3
Failure to Transmit Record 3 3
Defective Device 3 3
Missing Information 3 3
Erratic Results 3 3
Operating System Version or Upgrade Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Migration 3 3
Patient Data Problem 2 2
No Apparent Adverse Event 2 2
Output Problem 2 2
Device Dislodged or Dislocated 2 2
Failure to Disconnect 2 2
Charging Problem 2 2
Telemetry Discrepancy 2 2
Product Quality Problem 2 2
Incomplete or Missing Packaging 2 2
Radiofrequency Interference (RFI) 2 2
No Display/Image 2 2
Break 2 2
Image Display Error/Artifact 2 2
Labelling, Instructions for Use or Training Problem 2 2
Difficult to Interrogate 2 2
Pacing Intermittently 2 2
Misconnection 2 2
Incorrect Measurement 1 1
Pacing Inadequately 1 1
Material Rupture 1 1
Difficult to Insert 1 1
Failure to Back-Up 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Calibrate 1 1
Decreased Sensitivity 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Unable to Obtain Readings 1 1
Shipping Damage or Problem 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
High Sensing Threshold 1 1
Low Sensing Threshold 1 1
Patient-Device Incompatibility 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1548 1548
Unspecified Infection 336 336
No Known Impact Or Consequence To Patient 214 214
No Information 146 146
Insufficient Information 65 65
Shock from Patient Lead(s) 37 37
Pocket Erosion 24 24
Death 19 19
No Patient Involvement 17 17
Ventricular Fibrillation 16 16
No Consequences Or Impact To Patient 12 12
Ventricular Tachycardia 11 11
Electric Shock 11 11
Bacterial Infection 9 9
Sepsis 9 9
Atrial Fibrillation 8 8
Endocarditis 8 8
Hematoma 8 8
Syncope/Fainting 8 8
Tachycardia 8 8
Discomfort 8 8
Implant Pain 8 8
Dyspnea 7 7
Pain 7 7
Cardiac Arrest 6 6
Dizziness 6 6
Shock 5 5
Chest Pain 5 5
Failure of Implant 5 5
Pneumothorax 4 4
Arrhythmia 4 4
Wound Dehiscence 3 3
Bradycardia 3 3
Hemorrhage/Bleeding 3 3
Pneumonia 3 3
Fever 3 3
Asystole 3 3
Anxiety 3 3
Distress 2 2
Staphylococcus Aureus 2 2
Foreign Body In Patient 2 2
Loss of consciousness 2 2
Inflammation 2 2
Perforation 2 2
Swelling 2 2
Bruise/Contusion 2 2
Twiddlers Syndrome 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling/ Edema 1 1
No Code Available 1 1
Cardiopulmonary Arrest 1 1
Cellulitis 1 1
Muscle Stimulation 1 1
Abrasion 1 1
Hemothorax 1 1
Hyperbilirubinemia 1 1
Low Blood Pressure/ Hypotension 1 1
Fainting 1 1
Fatigue 1 1
Local Reaction 1 1
Liver Damage/Dysfunction 1 1
Necrosis 1 1
Foreign Body Reaction 1 1
Headache 1 1
Palpitations 1 1
Myocarditis 1 1
Sudden Cardiac Death 1 1
Diminished Pulse Pressure 1 1
Fluid Discharge 1 1
Not Applicable 1 1
Heart Failure/Congestive Heart Failure 1 1
Liver Failure 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Malaise 1 1
Impaired Healing 1 1
Numbness 1 1
Burning Sensation 1 1
Tingling 1 1
Heart Failure 1 1
Discharge 1 1
Viral Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BIOTRONIK Inc II Apr-21-2021
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