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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 671 671

Device Problems MDRs with this Device Problem Events in those MDRs
Reset Problem 795 795
Adverse Event Without Identified Device or Use Problem 717 717
Inappropriate or Unexpected Reset 534 534
Under-Sensing 530 530
Device Sensing Problem 423 423
Migration or Expulsion of Device 409 409
Over-Sensing 406 406
Signal Artifact/Noise 390 390
Communication or Transmission Problem 187 187
Output Problem 186 186
Premature Discharge of Battery 149 149
Failure to Interrogate 137 137
Data Problem 134 134
Mechanical Problem 110 110
Electromagnetic Interference 107 107
Unable to Obtain Readings 97 97
Premature Elective Replacement Indicator 53 53
Ambient Noise Problem 51 51
Failure to Sense 48 48
Decreased Sensitivity 38 38
Migration 37 37
Appropriate Term/Code Not Available 31 31
Battery Problem 30 30
Device Dislodged or Dislocated 29 29
False Positive Result 23 23
Device-Device Incompatibility 20 20
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
Battery Problem: High Impedance 7 7
Premature End-of-Life Indicator 7 7
Difficult to Insert 7 7
Break 7 7
Difficult to Remove 6 6
Off-Label Use 6 6
Positioning Problem 6 6
Human-Device Interface Problem 5 5
Failure to Analyze Signal 5 5
Use of Device 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 3659 3659
Wound Dehiscence 290 290
Unspecified Infection 289 289
Discomfort 126 126
Pocket Erosion 113 113
Pain 91 91
Erosion 88 88
Implant Pain 78 78
No Known Impact Or Consequence To Patient 71 71
Erythema 29 29
No Consequences Or Impact To Patient 20 20
Impaired Healing 20 20
Hemorrhage/Bleeding 18 18
Purulent Discharge 18 18
Hypersensitivity/Allergic reaction 16 16
Twiddlers Syndrome 16 16
Swelling/ Edema 16 16
Hematoma 15 15
Insufficient Information 13 13
Skin Inflammation/ Irritation 13 13
No Code Available 10 10
Inflammation 10 10
Fluid Discharge 8 8
Burning Sensation 6 6
Failure of Implant 5 5
Skin Erosion 5 5
Itching Sensation 5 5
Rash 5 5
Chest Pain 5 5
Bacterial Infection 5 5
Sepsis 4 4
Anxiety 3 3
Unspecified Tissue Injury 3 3
Arrhythmia 3 3
Atrial Fibrillation 3 3
Cellulitis 3 3
Perforation 3 3
Scar Tissue 2 2
Laceration(s) 2 2
Fever 2 2
Abscess 2 2
Bruise/Contusion 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
Hyperventilation 1 1
Fall 1 1
Irritation 1 1
Pneumothorax 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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