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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
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 226 226
2018 1819 1819
2019 1593 1593
2020 1100 1100
2021 832 832
2022 522 522

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3105 3105
Over-Sensing 722 722
Failure to Interrogate 481 481
Data Problem 396 396
Adverse Event Without Identified Device or Use Problem 348 348
Signal Artifact/Noise 276 276
Premature Discharge of Battery 220 220
Failure to Sense 150 150
Incorrect Measurement 130 130
Device Sensing Problem 115 115
Inappropriate or Unexpected Reset 113 113
Wireless Communication Problem 102 102
Incorrect Interpretation of Signal 95 95
Communication or Transmission Problem 94 94
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Migration or Expulsion of Device 67 67
Sensing Intermittently 62 62
Device Operates Differently Than Expected 48 48
Detachment of Device or Device Component 43 43
Interrogation Problem 43 43
Difficult to Interrogate 41 41
Migration 36 36
Device Displays Incorrect Message 29 29
Appropriate Term/Code Not Available 26 26
Telemetry Discrepancy 25 25
Decreased Sensitivity 22 22
Use of Device Problem 22 22
Break 21 21
Low Sensing Threshold 17 17
Application Program Version or Upgrade Problem 15 15
Battery Problem 15 15
Pacemaker Found in Back-Up Mode 15 15
Premature Elective Replacement Indicator 14 14
Insufficient Information 9 9
Reset Problem 7 7
No Apparent Adverse Event 6 6
Failure to Transmit Record 6 6
Failure to Capture 6 6
Connection Problem 5 5
Device Dislodged or Dislocated 5 5
Intermittent Communication Failure 5 5
Defective Device 4 4
Electromagnetic Interference 4 4
Computer Software Problem 4 4
Use of Incorrect Control/Treatment Settings 3 3
Image Display Error/Artifact 3 3
Device Difficult to Program or Calibrate 3 3
Improper or Incorrect Procedure or Method 3 3
Cut In Material 3 3
Loss of Data 3 3
Computer Operating System Problem 2 2
Operating System Version or Upgrade Problem 2 2
Out-Of-Box Failure 2 2
Dull, Blunt 2 2
Failure to Disconnect 2 2
Loose or Intermittent Connection 2 2
Detachment Of Device Component 2 2
Unintended Movement 2 2
Issue With Displayed Error Message 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Temperature Problem 1 1
Missing Information 1 1
Excessive Heating 1 1
Missing Test Results 1 1
False Device Output 1 1
Fracture 1 1
Material Fragmentation 1 1
Display or Visual Feedback Problem 1 1
Misconnection 1 1
Overheating of Device 1 1
Pocket Stimulation 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Failure to Analyze Signal 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Read Input Signal 1 1
Application Program Problem 1 1
Failure to Advance 1 1
Device Damaged Prior to Use 1 1
Device Inoperable 1 1
Positioning Problem 1 1
Power Problem 1 1
Programming Issue 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Computer System Security Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4039 4039
No Clinical Signs, Symptoms or Conditions 1250 1250
No Consequences Or Impact To Patient 317 317
Pocket Erosion 119 119
Unspecified Infection 116 116
Erosion 65 65
No Patient Involvement 56 56
Discomfort 54 54
No Information 32 32
Wound Dehiscence 28 28
Insufficient Information 23 23
Pain 20 20
Syncope 18 18
Hematoma 12 12
Twiddlers Syndrome 12 12
Complaint, Ill-Defined 9 9
Dizziness 8 8
Bradycardia 7 7
Cardiac Arrest 4 4
Atrial Fibrillation 4 4
Dyspnea 4 4
Hypersensitivity/Allergic reaction 4 4
Palpitations 4 4
Burning Sensation 3 3
No Code Available 3 3
Hemorrhage/Bleeding 3 3
Erythema 2 2
Arrhythmia 2 2
Chest Pain 2 2
Death 2 2
Anxiety 2 2
Impaired Healing 2 2
Reaction 1 1
Post Operative Wound Infection 1 1
Injury 1 1
Skin Tears 1 1
Blood Loss 1 1
Complete Heart Block 1 1
Distress 1 1
Excessive Tear Production 1 1
Urticaria 1 1
Blurred Vision 1 1
Syncope/Fainting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Purulent Discharge 1 1
Fainting 1 1
Fever 1 1
Headache 1 1
Stroke/CVA 1 1
Abrasion 1 1
Abscess 1 1
Hemostasis 1 1
Irritation 1 1
Itching Sensation 1 1
Nausea 1 1
Rash 1 1
Scar Tissue 1 1
Seizures 1 1
Shock 1 1
Swelling 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-25-2019
2 St Jude Medical Inc. II Jun-29-2018
3 St Jude Medical, Cardiac Rhythm Management Division II Jan-13-2020
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