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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
  1.  K182981  Confirm Rx Insertable Cardiac Monitor
  2.  K192593  Confirm Rx Insertable Cardiac Monitor
ABBOTT (ST. JUDE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 5
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRANSOMA
  SUBSTANTIALLY EQUIVALENT 1
TRANSOMA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 598 598
2015 235 235
2016 194 194
2017 226 226
2018 1819 1819
2019 1593 1593
2020 1100 1100
2021 832 832
2022 628 628
2023 828 828
2024 628 628

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3939 3939
Over-Sensing 1044 1044
Failure to Interrogate 869 869
Adverse Event Without Identified Device or Use Problem 444 444
Data Problem 432 432
Signal Artifact/Noise 352 352
Premature Discharge of Battery 313 313
Incorrect Measurement 258 258
Pacemaker Found in Back-Up Mode 255 255
Failure to Sense 232 232
Device Displays Incorrect Message 218 218
Device Sensing Problem 159 159
Device Operates Differently Than Expected 155 155
Inappropriate or Unexpected Reset 135 135
Incorrect, Inadequate or Imprecise Result or Readings 122 122
Sensing Intermittently 121 121
Incorrect Interpretation of Signal 108 108
Wireless Communication Problem 105 105
Migration or Expulsion of Device 103 103
Communication or Transmission Problem 100 100
Interrogation Problem 99 99
Detachment of Device or Device Component 55 55
Difficult to Interrogate 52 52
Telemetry Discrepancy 42 42
Migration 40 40
Appropriate Term/Code Not Available 33 33
Break 27 27
Use of Device Problem 26 26
Decreased Sensitivity 24 24
Premature Elective Replacement Indicator 23 23
Battery Problem 22 22
No Apparent Adverse Event 21 21
Insufficient Information 17 17
Low Sensing Threshold 17 17
Application Program Version or Upgrade Problem 15 15
Computer Software Problem 14 14
Electromagnetic Interference 10 10
Out-Of-Box Failure 8 8
Failure to Capture 7 7
Reset Problem 7 7
Failure to Transmit Record 6 6
Improper or Incorrect Procedure or Method 5 5
Intermittent Communication Failure 5 5
Loss of Data 5 5
Problem with Software Installation 5 5
Defective Device 5 5
Programming Issue 5 5
Connection Problem 5 5
Device Dislodged or Dislocated 5 5
Image Display Error/Artifact 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4984 4984
No Clinical Signs, Symptoms or Conditions 2693 2693
No Consequences Or Impact To Patient 317 317
Unspecified Infection 162 162
Pocket Erosion 146 146
Discomfort 85 85
No Patient Involvement 82 82
Erosion 80 80
Insufficient Information 69 69
Wound Dehiscence 48 48
No Information 32 32
Syncope 27 27
Pain 26 26
Death 15 15
Hematoma 13 13
Twiddlers Syndrome 12 12
Complaint, Ill-Defined 11 11
Dizziness 11 11
Cardiac Arrest 11 11
Bradycardia 9 9
Arrhythmia 7 7
Hypersensitivity/Allergic reaction 5 5
No Code Available 5 5
Hemorrhage/Bleeding 5 5
Dyspnea 4 4
Atrial Fibrillation 4 4
Palpitations 4 4
Chest Pain 3 3
Burning Sensation 3 3
Fever 3 3
Anxiety 3 3
Fainting 3 3
Tachycardia 2 2
Therapeutic Effects, Unexpected 2 2
Erythema 2 2
Scar Tissue 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Impaired Healing 2 2
Shock 1 1
Skin Tears 1 1
Abscess 1 1
Blurred Vision 1 1
Reaction 1 1
Collapse 1 1
Achalasia 1 1
Headache 1 1
Excessive Tear Production 1 1
Device Embedded In Tissue or Plaque 1 1
Distress 1 1
Hemostasis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-25-2019
2 St Jude Medical CRMD II Jul-05-2011
3 St Jude Medical Inc. II Jun-29-2018
4 St Jude Medical, Cardiac Rhythm Management Division II Jan-13-2020
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