Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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 226 226

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3774 3774
Over-Sensing 989 989
Failure to Interrogate 791 791
Adverse Event Without Identified Device or Use Problem 431 431
Data Problem 421 421
Signal Artifact/Noise 335 335
Premature Discharge of Battery 293 293
Pacemaker Found in Back-Up Mode 255 255
Failure to Sense 228 228
Device Displays Incorrect Message 218 218
Incorrect Measurement 214 214
Device Operates Differently Than Expected 155 155
Device Sensing Problem 152 152
Inappropriate or Unexpected Reset 129 129
Sensing Intermittently 118 118
Incorrect, Inadequate or Imprecise Result or Readings 114 114
Incorrect Interpretation of Signal 106 106
Wireless Communication Problem 104 104
Communication or Transmission Problem 99 99
Migration or Expulsion of Device 95 95
Interrogation Problem 82 82
Difficult to Interrogate 52 52
Detachment of Device or Device Component 51 51
Telemetry Discrepancy 42 42
Migration 39 39
Appropriate Term/Code Not Available 33 33
Break 26 26
Decreased Sensitivity 24 24
Use of Device Problem 23 23
Premature Elective Replacement Indicator 23 23
Battery Problem 22 22
Low Sensing Threshold 17 17
Application Program Version or Upgrade Problem 15 15
No Apparent Adverse Event 15 15
Insufficient Information 15 15
Computer Software Problem 11 11
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
Defective Device 5 5
Connection Problem 5 5
Loss of Data 5 5
Problem with Software Installation 5 5
Programming Issue 5 5
Device Dislodged or Dislocated 5 5
Intermittent Communication Failure 5 5
Image Display Error/Artifact 4 4
Use of Incorrect Control/Treatment Settings 3 3
Device Difficult to Program or Calibrate 3 3
Computer Operating System Problem 3 3
Cut In Material 3 3
Dull, Blunt 2 2
Invalid Sensing 2 2
Material Separation 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Device-Device Incompatibility 2 2
Patient-Device Incompatibility 2 2
Application Program Problem 2 2
Failure to Disconnect 2 2
Product Quality Problem 2 2
Detachment Of Device Component 2 2
Loose or Intermittent Connection 2 2
Unintended Movement 2 2
Operating System Version or Upgrade Problem 2 2
Issue With Displayed Error Message 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Temperature Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Missing Test Results 1 1
No Pacing 1 1
Excessive Heating 1 1
Missing Information 1 1
False Device Output 1 1
Fracture 1 1
Material Fragmentation 1 1
Crack 1 1
Display or Visual Feedback Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Unable to Obtain Readings 1 1
Misconnection 1 1
Nonstandard Device 1 1
No Device Output 1 1
Overheating of Device 1 1
Difficult to Remove 1 1
Pocket Stimulation 1 1
Failure to Analyze Signal 1 1
Year 2000 (Y2K) related problem 1 1
Low Battery 1 1
Computer System Security Problem 1 1
Calibration Problem 1 1
Failure to Read Input Signal 1 1
Shelf Life Exceeded 1 1
Electro-Static Discharge 1 1
Device Damaged Prior to Use 1 1

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 2312 2312
No Consequences Or Impact To Patient 317 317
Unspecified Infection 153 153
Pocket Erosion 142 142
No Patient Involvement 82 82
Discomfort 81 81
Erosion 80 80
Insufficient Information 61 61
Wound Dehiscence 42 42
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
Palpitations 4 4
Hemorrhage/Bleeding 4 4
Atrial Fibrillation 4 4
Dyspnea 4 4
Fainting 3 3
Fever 3 3
Chest Pain 3 3
Anxiety 3 3
Burning Sensation 3 3
Tachycardia 2 2
Therapeutic Effects, Unexpected 2 2
Impaired Healing 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Scar Tissue 2 2
Erythema 2 2
Fall 1 1
Stroke/CVA 1 1
Purulent Discharge 1 1
Abrasion 1 1
Abscess 1 1
Achalasia 1 1
Seizures 1 1
Shock 1 1
Swelling 1 1
Rash 1 1
Foreign Body Reaction 1 1
Headache 1 1
Hemostasis 1 1
Irritation 1 1
Itching Sensation 1 1
Nausea 1 1
Syncope/Fainting 1 1
Skin Tears 1 1
Blood Loss 1 1
Complete Heart Block 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Shock from Patient Lead(s) 1 1
Device Embedded In Tissue or Plaque 1 1
Reaction 1 1
Collapse 1 1
Post Operative Wound Infection 1 1
Distress 1 1
Injury 1 1
Blurred Vision 1 1
Excessive Tear Production 1 1
Urticaria 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
-
-