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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)
2021 2022 2023 2024 2025 2026
18 9 20 19 23 9

MDR Year MDR Reports MDR Events
2021 575 577
2022 505 506
2023 551 553
2024 514 524
2025 454 454
2026 197 197

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Elective Replacement Indicator 1299 1299
Premature End-of-Life Indicator 446 446
Adverse Event Without Identified Device or Use Problem 402 402
Failure to Interrogate 107 108
Battery Problem 98 99
Over-Sensing 68 69
Inappropriate/Inadequate Shock/Stimulation 52 52
Premature Discharge of Battery 41 41
High impedance 35 35
Display or Visual Feedback Problem 27 27
Insufficient Information 26 26
Application Program Freezes, Becomes Nonfunctional 18 25
Low impedance 16 16
Failure to Deliver Shock/Stimulation 15 15
Communication or Transmission Problem 14 14
Computer Software Problem 13 15
Ambient Noise Problem 11 11
Connection Problem 10 10
Inappropriate or Unexpected Reset 9 9
Impedance Problem 9 9
Device Displays Incorrect Message 8 8
Pacing Problem 8 8
Data Problem 8 8
Defibrillation/Stimulation Problem 7 7
Signal Artifact/Noise 7 7
Migration or Expulsion of Device 7 7
Wireless Communication Problem 6 6
Defective Component 6 6
Program or Algorithm Execution Problem 6 7
Pacemaker Found in Back-Up Mode 6 6
Appropriate Term/Code Not Available 6 7
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Failure to Convert Rhythm 5 5
Unexpected Therapeutic Results 5 5
Installation-Related Problem 5 6
Under-Sensing 5 5
High Capture Threshold 4 4
Loss of Data 4 5
Patient Device Interaction Problem 4 4
No Pacing 4 4
Packaging Problem 4 4
Fracture 4 4
Erratic or Intermittent Display 4 4
Application Program Problem 4 4
Erratic Results 3 3
Defective Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Patient Data Problem 3 3
Inaccurate Information 3 3
Failure to Capture 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2208 2221
Unspecified Infection 312 312
Insufficient Information 76 78
Shock from Patient Lead(s) 29 29
Ventricular Fibrillation 29 29
Pocket Erosion 26 26
Tachycardia 17 17
Atrial Fibrillation 9 9
Endocarditis 8 8
Syncope/Fainting 7 7
Dizziness 7 7
Hematoma 7 7
Cardiac Arrest 7 7
Implant Pain 7 7
Bacterial Infection 6 6
Electric Shock 6 6
Failure of Implant 6 6
Discomfort 6 6
No Known Impact Or Consequence To Patient 6 6
Arrhythmia 5 5
Sepsis 5 5
Chest Pain 5 5
No Consequences Or Impact To Patient 4 4
Shock 4 4
Asystole 4 4
Dyspnea 4 4
No Information 4 4
Ischemic Heart Disease 3 3
Pneumothorax 3 3
Hemorrhage/Bleeding 3 3
Inflammation 2 2
Burning Sensation 2 2
Foreign Body In Patient 2 2
Ventricular Tachycardia 2 2
Twiddlers Syndrome 2 2
Pain 2 2
Bradycardia 2 2
Heart Failure/Congestive Heart Failure 2 2
Swelling/ Edema 2 2
Loss of consciousness 2 2
Perforation 1 1
Malaise 1 1
Local Reaction 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Foreign Body Reaction 1 1
Myocarditis 1 1
Necrosis 1 1
Fever 1 1
Hyperbilirubinemia 1 1

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