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

MDR Year MDR Reports MDR Events
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 2573 2573
Over-Sensing 855 855
Failure to Interrogate 578 578
Adverse Event Without Identified Device or Use Problem 332 332
Signal Artifact/Noise 277 277
Data Problem 254 254
Premature Discharge of Battery 250 250
Incorrect Measurement 247 247
Failure to Sense 148 148
Incorrect, Inadequate or Imprecise Result or Readings 122 122
Device Sensing Problem 120 120
Interrogation Problem 97 97
Incorrect Interpretation of Signal 87 87
Migration or Expulsion of Device 79 79
Inappropriate or Unexpected Reset 73 73
Wireless Communication Problem 71 71
Communication or Transmission Problem 62 62
Detachment of Device or Device Component 52 52
Sensing Intermittently 36 36
Migration 33 33
Break 24 24
Use of Device Problem 23 23
No Apparent Adverse Event 21 21
Difficult to Interrogate 17 17
Appropriate Term/Code Not Available 17 17
Battery Problem 16 16
Insufficient Information 15 15
Application Program Version or Upgrade Problem 14 14
Low Sensing Threshold 14 14
Computer Software Problem 9 9
Telemetry Discrepancy 8 8
Decreased Sensitivity 7 7
Reset Problem 6 6
Device Displays Incorrect Message 6 6
Defective Device 5 5
Failure to Transmit Record 5 5
Premature Elective Replacement Indicator 5 5
Pacemaker Found in Back-Up Mode 5 5
Failure to Capture 4 4
Improper or Incorrect Procedure or Method 4 4
Intermittent Communication Failure 4 4
Use of Incorrect Control/Treatment Settings 3 3
Loss of Data 3 3
Device Dislodged or Dislocated 3 3
Failure to Advance 2 2
Computer Operating System Problem 2 2
Operating System Version or Upgrade Problem 2 2
Failure to Disconnect 2 2
Connection Problem 2 2
Material Separation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2693 2693
No Known Impact Or Consequence To Patient 2189 2189
No Consequences Or Impact To Patient 296 296
Unspecified Infection 113 113
Pocket Erosion 108 108
Discomfort 76 76
Insufficient Information 69 69
Erosion 50 50
Wound Dehiscence 45 45
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
Hemorrhage/Bleeding 5 5
Dizziness 5 5
Bradycardia 4 4
Twiddlers Syndrome 3 3
Dyspnea 3 3
Burning Sensation 3 3
Hypersensitivity/Allergic reaction 3 3
Atrial Fibrillation 2 2
Palpitations 2 2
Fever 2 2
Erythema 2 2
Scar Tissue 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 1 1
Abrasion 1 1
Purulent Discharge 1 1
Itching Sensation 1 1
Blood Loss 1 1
Complete Heart Block 1 1
Shock from Patient Lead(s) 1 1
Post Operative Wound Infection 1 1
Seizures 1 1
Irritation 1 1
Rash 1 1
Foreign Body In Patient 1 1
Nausea 1 1
Failure of Implant 1 1
Fatigue 1 1
Chest Pain 1 1
Swelling 1 1
Stroke/CVA 1 1
Syncope/Fainting 1 1
Abscess 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
-
-