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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 0

MDR Year MDR Reports MDR Events
2019 345 345
2020 316 316
2021 575 575
2022 505 505
2023 557 557
2024 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 845 845
Adverse Event Without Identified Device or Use Problem 404 404
Premature End-of-Life Indicator 311 311
Over-Sensing 147 147
Battery Problem 111 111
Failure to Interrogate 104 104
Inappropriate/Inadequate Shock/Stimulation 92 92
High impedance 54 54
Premature Discharge of Battery 41 41
Display or Visual Feedback Problem 36 36
Low impedance 29 29
Communication or Transmission Problem 24 24
Insufficient Information 22 22
Data Problem 18 18
Device Displays Incorrect Message 16 16
Failure to Deliver Shock/Stimulation 15 15
Interrogation Problem 14 14
Inappropriate or Unexpected Reset 14 14
Application Program Freezes, Becomes Nonfunctional 13 13
Pacemaker Found in Back-Up Mode 9 9
Ambient Noise Problem 9 9
Device Sensing Problem 8 8
Migration or Expulsion of Device 8 8
No Pacing 8 8
Impedance Problem 8 8
Appropriate Term/Code Not Available 8 8
High Capture Threshold 7 7
Fracture 7 7
Nonstandard Device 7 7
Failure to Capture 7 7
Computer Software Problem 7 7
Connection Problem 7 7
Unexpected Therapeutic Results 7 7
Defective Component 6 6
Loss of Data 6 6
Delayed Charge Time 6 6
Signal Artifact/Noise 6 6
Electromagnetic Interference 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Pacing Problem 5 5
Under-Sensing 5 5
Program or Algorithm Execution Problem 5 5
Device Markings/Labelling Problem 5 5
Defibrillation/Stimulation Problem 5 5
Installation-Related Problem 4 4
Packaging Problem 4 4
Unexpected Shutdown 4 4
Wireless Communication Problem 4 4
Inaccurate Information 4 4
Failure to Sense 4 4
Mechanical Problem 4 4
Erratic or Intermittent Display 4 4
Electrical /Electronic Property Problem 3 3
Loose or Intermittent Connection 3 3
Failure to Convert Rhythm 3 3
Incorrect Interpretation of Signal 3 3
Failure to Transmit Record 3 3
Defective Device 3 3
Missing Information 3 3
Erratic Results 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 2 2
Output Problem 2 2
Charging Problem 2 2
Patient Data Problem 2 2
Migration 2 2
Application Program Problem 2 2
Device Dislodged or Dislocated 2 2
Incomplete or Missing Packaging 2 2
Radiofrequency Interference (RFI) 2 2
Telemetry Discrepancy 2 2
Failure to Disconnect 2 2
Pacing Intermittently 2 2
Product Quality Problem 2 2
Misconnection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Difficult to Interrogate 2 2
Image Display Error/Artifact 2 2
Break 2 2
Intermittent Capture 2 2
Failure to Back-Up 1 1
No Display/Image 1 1
Difficult to Insert 1 1
Incorrect Measurement 1 1
Pacing Inadequately 1 1
Unable to Obtain Readings 1 1
Material Rupture 1 1
High Sensing Threshold 1 1
Low Sensing Threshold 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Calibrate 1 1
Decreased Sensitivity 1 1
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Electrical Shorting 1 1
Electromagnetic Compatibility Problem 1 1
Expulsion 1 1
Detachment of Device or Device Component 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1390 1390
Unspecified Infection 322 322
No Known Impact Or Consequence To Patient 214 214
No Information 146 146
Insufficient Information 63 63
Shock from Patient Lead(s) 37 37
Pocket Erosion 23 23
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
Syncope/Fainting 8 8
Hematoma 8 8
Atrial Fibrillation 8 8
Implant Pain 8 8
Endocarditis 7 7
Sepsis 7 7
Tachycardia 7 7
Dyspnea 7 7
Cardiac Arrest 6 6
Discomfort 6 6
Dizziness 5 5
Chest Pain 5 5
Pain 5 5
Failure of Implant 5 5
Shock 5 5
Arrhythmia 4 4
Pneumothorax 4 4
Pneumonia 3 3
Wound Dehiscence 3 3
Bradycardia 3 3
Asystole 3 3
Anxiety 3 3
Foreign Body In Patient 2 2
Swelling 2 2
Inflammation 2 2
Twiddlers Syndrome 2 2
Perforation 2 2
Fever 2 2
Staphylococcus Aureus 2 2
Distress 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Loss of consciousness 2 2
Bruise/Contusion 2 2
Hemorrhage/Bleeding 2 2
Liver Damage/Dysfunction 1 1
Swelling/ Edema 1 1
Tingling 1 1
Liver Failure 1 1
Necrosis 1 1
Hyperbilirubinemia 1 1
Local Reaction 1 1
Skin Inflammation/ Irritation 1 1
Low Blood Pressure/ Hypotension 1 1
Fluid Discharge 1 1
Viral Infection 1 1
Muscle Stimulation 1 1
Blister 1 1
Headache 1 1
Numbness 1 1
Fainting 1 1
Cardiopulmonary Arrest 1 1
Discharge 1 1
Abrasion 1 1
Malaise 1 1
Heart Failure 1 1
No Code Available 1 1
Cellulitis 1 1
Foreign Body Reaction 1 1
Myocarditis 1 1
Diminished Pulse Pressure 1 1
Not Applicable 1 1
Hemothorax 1 1
Burning Sensation 1 1
Impaired Healing 1 1
Heart Failure/Congestive Heart Failure 1 1
Sudden Cardiac Death 1 1
Palpitations 1 1
Fatigue 1 1

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