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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)
2020 2021 2022 2023 2024 2025
23 18 9 20 19 19

MDR Year MDR Reports MDR Events
2020 316 316
2021 575 575
2022 505 505
2023 551 551
2024 514 514
2025 387 387

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 1251 1251
Premature End-of-Life Indicator 437 437
Adverse Event Without Identified Device or Use Problem 425 425
Failure to Interrogate 114 114
Battery Problem 106 106
Over-Sensing 106 106
Inappropriate/Inadequate Shock/Stimulation 66 66
High impedance 46 46
Premature Discharge of Battery 38 38
Display or Visual Feedback Problem 28 28
Insufficient Information 25 25
Low impedance 21 21
Application Program Freezes, Becomes Nonfunctional 20 20
Failure to Deliver Shock/Stimulation 13 13
Device Displays Incorrect Message 12 12
Data Problem 12 12
Communication or Transmission Problem 12 12
Inappropriate or Unexpected Reset 12 12
Computer Software Problem 12 12
High Capture Threshold 9 9
Migration or Expulsion of Device 9 9
Ambient Noise Problem 9 9
Connection Problem 9 9
Impedance Problem 9 9
Pacing Problem 9 9
Pacemaker Found in Back-Up Mode 8 8
Signal Artifact/Noise 7 7
Interrogation Problem 7 7
Defibrillation/Stimulation Problem 7 7
Appropriate Term/Code Not Available 7 7
Loss of Data 6 6
Failure to Capture 6 6
Program or Algorithm Execution Problem 6 6
Defective Component 6 6
Fracture 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Installation-Related Problem 5 5
Under-Sensing 5 5
Electromagnetic Interference 5 5
Unexpected Therapeutic Results 5 5
No Pacing 5 5
Device Markings/Labelling Problem 5 5
Failure to Convert Rhythm 5 5
Erratic or Intermittent Display 4 4
Patient Device Interaction Problem 4 4
Nonstandard Device 4 4
Device Sensing Problem 4 4
Application Program Problem 4 4
Packaging Problem 4 4
Inaccurate Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2086 2086
Unspecified Infection 344 344
No Known Impact Or Consequence To Patient 100 100
Insufficient Information 77 77
No Information 51 51
Pocket Erosion 29 29
Shock from Patient Lead(s) 29 29
Ventricular Fibrillation 17 17
Tachycardia 14 14
Endocarditis 9 9
Bacterial Infection 9 9
Sepsis 9 9
Electric Shock 9 9
No Consequences Or Impact To Patient 9 9
Dizziness 8 8
Implant Pain 8 8
Atrial Fibrillation 8 8
Syncope/Fainting 8 8
Hematoma 7 7
Cardiac Arrest 7 7
Discomfort 7 7
Chest Pain 7 7
Failure of Implant 6 6
Arrhythmia 6 6
Death 5 5
Shock 5 5
Asystole 5 5
Dyspnea 5 5
No Patient Involvement 5 5
Ventricular Tachycardia 4 4
Hemorrhage/Bleeding 3 3
Pneumothorax 3 3
Swelling/ Edema 3 3
Anxiety 3 3
Ischemic Heart Disease 3 3
Pain 3 3
Fever 3 3
Loss of consciousness 2 2
Twiddlers Syndrome 2 2
Bruise/Contusion 2 2
Foreign Body In Patient 2 2
Burning Sensation 2 2
Perforation 2 2
Inflammation 2 2
Wound Dehiscence 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Myocarditis 1 1
Palpitations 1 1
Foreign Body Reaction 1 1
Blister 1 1

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