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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, (without arrhythmia detection)
Product CodeMXC
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT (ST. JUDE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 5
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1593 1593
2020 1100 1100
2021 832 832
2022 628 628
2023 828 828
2024 307 307

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 2447 2447
Over-Sensing 811 811
Failure to Interrogate 511 511
Adverse Event Without Identified Device or Use Problem 323 323
Signal Artifact/Noise 263 263
Data Problem 246 246
Premature Discharge of Battery 232 232
Incorrect Measurement 216 216
Failure to Sense 145 145
Incorrect, Inadequate or Imprecise Result or Readings 117 117
Device Sensing Problem 114 114
Incorrect Interpretation of Signal 86 86
Interrogation Problem 81 81
Migration or Expulsion of Device 72 72
Wireless Communication Problem 70 70
Inappropriate or Unexpected Reset 67 67
Communication or Transmission Problem 61 61
Detachment of Device or Device Component 49 49
Sensing Intermittently 33 33
Migration 32 32
Break 23 23
Use of Device Problem 20 20
Appropriate Term/Code Not Available 17 17
Difficult to Interrogate 17 17
Battery Problem 16 16
No Apparent Adverse Event 15 15
Application Program Version or Upgrade Problem 14 14
Insufficient Information 14 14
Low Sensing Threshold 14 14
Telemetry Discrepancy 8 8
Computer Software Problem 7 7
Decreased Sensitivity 7 7
Device Displays Incorrect Message 6 6
Reset Problem 6 6
Premature Elective Replacement Indicator 5 5
Pacemaker Found in Back-Up Mode 5 5
Defective Device 5 5
Failure to Transmit Record 5 5
Intermittent Communication Failure 4 4
Failure to Capture 4 4
Improper or Incorrect Procedure or Method 4 4
Loss of Data 3 3
Device Dislodged or Dislocated 3 3
Use of Incorrect Control/Treatment Settings 3 3
Computer Operating System Problem 2 2
Material Separation 2 2
Operating System Version or Upgrade Problem 2 2
Failure to Disconnect 2 2
Connection Problem 2 2
Product Quality Problem 2 2
Compatibility Problem 2 2
Missing Information 1 1
Failure to Advance 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Misconnection 1 1
Difficult to Remove 1 1
Computer System Security Problem 1 1
Fracture 1 1
Missing Test Results 1 1
Unable to Obtain Readings 1 1
Dull, Blunt 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Overheating of Device 1 1
Display or Visual Feedback Problem 1 1
Application Program Problem 1 1
Electromagnetic Interference 1 1
Unintended Movement 1 1
Device-Device Incompatibility 1 1
Therapy Delivered to Incorrect Body Area 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2388 2388
No Known Impact Or Consequence To Patient 2189 2189
No Consequences Or Impact To Patient 296 296
Unspecified Infection 107 107
Pocket Erosion 104 104
Discomfort 72 72
Insufficient Information 63 63
Erosion 50 50
Wound Dehiscence 41 41
No Patient Involvement 25 25
Pain 16 16
No Information 11 11
Hematoma 10 10
Syncope 9 9
Arrhythmia 7 7
Complaint, Ill-Defined 6 6
Dizziness 5 5
Hemorrhage/Bleeding 5 5
Bradycardia 4 4
Dyspnea 3 3
Hypersensitivity/Allergic reaction 3 3
Burning Sensation 3 3
Twiddlers Syndrome 3 3
Scar Tissue 2 2
Erythema 2 2
Fever 2 2
Atrial Fibrillation 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Palpitations 2 2
Skin Tears 1 1
Blood Loss 1 1
Complete Heart Block 1 1
Impaired Healing 1 1
Post Operative Wound Infection 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Shock from Patient Lead(s) 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Urticaria 1 1
Anxiety 1 1
Purulent Discharge 1 1
Headache 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Abrasion 1 1
Abscess 1 1
Seizures 1 1
Swelling 1 1
Tachycardia 1 1
Blurred Vision 1 1
Rash 1 1
Irritation 1 1
Itching Sensation 1 1
Nausea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-25-2019
2 St Jude Medical, Cardiac Rhythm Management Division II Jan-13-2020
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