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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device recorder, event, implantable cardiac, (with arrhythmia detection)
Product CodeMXD
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
MEDTRONIC. INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 70 70
2020 228 228
2021 694 694
2022 1362 1362
2023 1766 1766
2024 916 916

Device Problems MDRs with this Device Problem Events in those MDRs
Reset Problem 850 850
Adverse Event Without Identified Device or Use Problem 745 745
Inappropriate or Unexpected Reset 556 556
Under-Sensing 543 543
Device Sensing Problem 434 434
Signal Artifact/Noise 422 422
Over-Sensing 420 420
Migration or Expulsion of Device 417 417
Output Problem 254 254
Communication or Transmission Problem 189 189
Premature Discharge of Battery 160 160
Data Problem 144 144
Failure to Interrogate 143 143
Electromagnetic Interference 112 112
Mechanical Problem 110 110
Unable to Obtain Readings 101 101
Premature Elective Replacement Indicator 53 53
Ambient Noise Problem 52 52
Failure to Sense 48 48
Decreased Sensitivity 39 39
Migration 37 37
Appropriate Term/Code Not Available 33 33
Battery Problem 30 30
Device Dislodged or Dislocated 29 29
False Positive Result 23 23
Device-Device Incompatibility 21 21
Failure to Read Input Signal 16 16
Loss of Data 14 14
Device Displays Incorrect Message 12 12
Failure to Transmit Record 10 10
Expulsion 9 9
Malposition of Device 8 8
Material Integrity Problem 8 8
Break 8 8
Difficult to Insert 7 7
Premature End-of-Life Indicator 7 7
Battery Problem: High Impedance 7 7
Positioning Problem 6 6
Difficult to Remove 6 6
Off-Label Use 6 6
Failure to Analyze Signal 5 5
Use of Device Problem 5 5
Human-Device Interface Problem 5 5
Application Program Problem 4 4
Protective Measures Problem 4 4
Device Damaged by Another Device 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Connection Problem 3 3
Inadequate or Insufficient Training 3 3
Difficult or Delayed Positioning 3 3
Electrical /Electronic Property Problem 2 2
Overheating of Device 2 2
Pacemaker Found in Back-Up Mode 2 2
Defective Device 2 2
Device Markings/Labelling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Patient Device Interaction Problem 1 1
Patient-Device Incompatibility 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Cut 1 1
Fracture 1 1
Incorrect Measurement 1 1
Positioning Failure 1 1
Failure to Charge 1 1
Interrogation Problem 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3870 3870
Wound Dehiscence 300 300
Unspecified Infection 298 298
Discomfort 133 133
Pocket Erosion 114 114
Pain 95 95
Erosion 91 91
Implant Pain 81 81
No Known Impact Or Consequence To Patient 71 71
Erythema 31 31
Impaired Healing 22 22
No Consequences Or Impact To Patient 20 20
Hemorrhage/Bleeding 20 20
Purulent Discharge 19 19
Swelling/ Edema 18 18
Twiddlers Syndrome 16 16
Hypersensitivity/Allergic reaction 16 16
Hematoma 16 16
Insufficient Information 14 14
Skin Inflammation/ Irritation 13 13
No Code Available 10 10
Inflammation 10 10
Fluid Discharge 8 8
Itching Sensation 7 7
Rash 6 6
Failure of Implant 6 6
Burning Sensation 6 6
Skin Erosion 5 5
Chest Pain 5 5
Bacterial Infection 5 5
Arrhythmia 4 4
Bruise/Contusion 4 4
Sepsis 4 4
Anxiety 3 3
Unspecified Tissue Injury 3 3
Atrial Fibrillation 3 3
Cellulitis 3 3
Fever 3 3
Perforation 3 3
Scar Tissue 2 2
Laceration(s) 2 2
Abscess 2 2
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Twiddlers Syndrome 2 2
Swelling 1 1
Tachycardia 1 1
Thrombus 1 1
Distress 1 1
Pressure Sores 1 1
Numbness 1 1
Loss of consciousness 1 1
Blood Loss 1 1
Reaction to Medicinal Component of Device 1 1
Contact Dermatitis 1 1
Pericardial Effusion 1 1
Syncope/Fainting 1 1
Paresthesia 1 1
Thrombosis/Thrombus 1 1
Asystole 1 1
Device Embedded In Tissue or Plaque 1 1
Fasciitis 1 1
Cardiomyopathy 1 1
Burn(s) 1 1
Dyspnea 1 1
Ecchymosis 1 1
Endocarditis 1 1
Bradycardia 1 1
Pulmonary Embolism 1 1
Irritation 1 1
Pneumothorax 1 1
Hyperventilation 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Dec-01-2023
2 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Mar-11-2022
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-20-2021
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-14-2021
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