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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 0

MDR Year MDR Reports MDR Events
2020 316 316
2021 575 575
2022 505 505
2023 557 557
2024 525 525

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 1065 1065
Adverse Event Without Identified Device or Use Problem 376 376
Premature End-of-Life Indicator 358 358
Failure to Interrogate 98 98
Over-Sensing 97 97
Battery Problem 95 95
Inappropriate/Inadequate Shock/Stimulation 59 59
High impedance 43 43
Display or Visual Feedback Problem 29 29
Premature Discharge of Battery 28 28
Application Program Freezes, Becomes Nonfunctional 26 26
Insufficient Information 22 22
Low impedance 19 19
Computer Software Problem 18 18
Failure to Deliver Shock/Stimulation 13 13
Data Problem 13 13
Device Displays Incorrect Message 12 12
Communication or Transmission Problem 11 11
Inappropriate or Unexpected Reset 11 11
High Capture Threshold 9 9
Connection Problem 9 9
Migration or Expulsion of Device 8 8
Pacemaker Found in Back-Up Mode 8 8
Impedance Problem 8 8
Signal Artifact/Noise 7 7
Interrogation Problem 7 7
Application Program Problem 7 7
Appropriate Term/Code Not Available 7 7
Ambient Noise Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Loss of Data 6 6
Fracture 6 6
Failure to Capture 6 6
Program or Algorithm Execution Problem 6 6
Defective Component 6 6
Unexpected Therapeutic Results 5 5
Device Markings/Labelling Problem 5 5
Electromagnetic Interference 5 5
No Pacing 5 5
Under-Sensing 5 5
Pacing Problem 5 5
Erratic or Intermittent Display 5 5
Installation-Related Problem 5 5
Failure to Convert Rhythm 4 4
Packaging Problem 4 4
Defibrillation/Stimulation Problem 4 4
Device Sensing Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Inaccurate Information 3 3
Operating System Version or Upgrade Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1785 1785
Unspecified Infection 304 304
No Known Impact Or Consequence To Patient 100 100
Insufficient Information 73 73
No Information 51 51
Pocket Erosion 26 26
Shock from Patient Lead(s) 25 25
Ventricular Fibrillation 16 16
Tachycardia 12 12
Electric Shock 9 9
No Consequences Or Impact To Patient 9 9
Sepsis 9 9
Syncope/Fainting 8 8
Bacterial Infection 8 8
Implant Pain 8 8
Endocarditis 7 7
Dizziness 7 7
Atrial Fibrillation 7 7
Hematoma 6 6
Chest Pain 6 6
Discomfort 6 6
Death 5 5
Arrhythmia 5 5
Failure of Implant 5 5
Shock 5 5
Dyspnea 5 5
No Patient Involvement 5 5
Cardiac Arrest 5 5
Ventricular Tachycardia 4 4
Hemorrhage/Bleeding 3 3
Pneumothorax 3 3
Anxiety 3 3
Asystole 3 3
Pain 3 3
Fever 3 3
Bruise/Contusion 2 2
Loss of consciousness 2 2
Swelling/ Edema 2 2
Twiddlers Syndrome 2 2
Foreign Body In Patient 2 2
Burning Sensation 2 2
Inflammation 2 2
Perforation 2 2
Wound Dehiscence 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body Reaction 1 1
Myocarditis 1 1
Swelling 1 1
Palpitations 1 1
Local Reaction 1 1

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