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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 13

MDR Year MDR Reports MDR Events
2019 345 345
2020 316 316
2021 575 575
2022 505 505
2023 557 557
2024 390 390

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 1004 1004
Adverse Event Without Identified Device or Use Problem 440 440
Premature End-of-Life Indicator 365 365
Over-Sensing 149 149
Battery Problem 120 120
Failure to Interrogate 119 119
Inappropriate/Inadequate Shock/Stimulation 94 94
High impedance 59 59
Premature Discharge of Battery 45 45
Display or Visual Feedback Problem 39 39
Low impedance 29 29
Application Program Freezes, Becomes Nonfunctional 28 28
Communication or Transmission Problem 24 24
Insufficient Information 23 23
Data Problem 21 21
Computer Software Problem 17 17
Inappropriate or Unexpected Reset 17 17
Failure to Deliver Shock/Stimulation 17 17
Device Displays Incorrect Message 16 16
Interrogation Problem 14 14
Pacemaker Found in Back-Up Mode 10 10
Migration or Expulsion of Device 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Device Sensing Problem 9 9
Ambient Noise Problem 9 9
High Capture Threshold 9 9
No Pacing 8 8
Connection Problem 8 8
Appropriate Term/Code Not Available 8 8
Impedance Problem 8 8
Unexpected Therapeutic Results 7 7
Nonstandard Device 7 7
Fracture 7 7
Loss of Data 7 7
Failure to Capture 7 7
Signal Artifact/Noise 7 7
Electromagnetic Interference 6 6
Defective Component 6 6
Pacing Problem 6 6
Delayed Charge Time 6 6
Program or Algorithm Execution Problem 6 6
Device Markings/Labelling Problem 5 5
Application Program Problem 5 5
Wireless Communication Problem 5 5
Under-Sensing 5 5
Erratic or Intermittent Display 5 5
Installation-Related Problem 5 5
Defibrillation/Stimulation Problem 5 5
Inaccurate Information 4 4
Electrical /Electronic Property Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1680 1680
Unspecified Infection 352 352
No Known Impact Or Consequence To Patient 214 214
No Information 146 146
Insufficient Information 69 69
Shock from Patient Lead(s) 38 38
Pocket Erosion 25 25
Death 19 19
No Patient Involvement 17 17
Ventricular Fibrillation 17 17
No Consequences Or Impact To Patient 12 12
Electric Shock 11 11
Tachycardia 11 11
Ventricular Tachycardia 11 11
Bacterial Infection 9 9
Sepsis 9 9
Syncope/Fainting 8 8
Endocarditis 8 8
Hematoma 8 8
Implant Pain 8 8
Discomfort 8 8
Atrial Fibrillation 8 8
Dizziness 7 7
Pain 7 7
Dyspnea 7 7
Cardiac Arrest 6 6
Arrhythmia 5 5
Failure of Implant 5 5
Shock 5 5
Chest Pain 5 5
Pneumothorax 4 4
Hemorrhage/Bleeding 3 3
Anxiety 3 3
Asystole 3 3
Pneumonia 3 3
Bradycardia 3 3
Fever 3 3
Wound Dehiscence 3 3
Distress 2 2
Staphylococcus Aureus 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Loss of consciousness 2 2
Burning Sensation 2 2
Foreign Body In Patient 2 2
Swelling 2 2
Twiddlers Syndrome 2 2
Perforation 2 2
Inflammation 2 2
Swelling/ Edema 2 2

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