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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)
Regulation Description Medical magnetic tape recorder.
Product CodeMXC
Regulation Number 870.2800
Device Class 2


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

MDR Year MDR Reports MDR Events
2021 832 834
2022 628 628
2023 828 829
2024 975 976
2025 1123 1123
2026 224 224

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 1712 1713
Failure to Interrogate 890 891
Over-Sensing 732 732
Incorrect Measurement 313 313
Premature Discharge of Battery 277 277
Adverse Event Without Identified Device or Use Problem 229 229
Signal Artifact/Noise 169 169
Interrogation Problem 143 144
Incorrect, Inadequate or Imprecise Result or Readings 134 134
Inappropriate or Unexpected Reset 120 120
Failure to Sense 117 117
Data Problem 111 111
Device Sensing Problem 95 95
Migration or Expulsion of Device 83 83
Detachment of Device or Device Component 44 44
No Apparent Adverse Event 41 42
Incorrect Interpretation of Signal 38 38
Wireless Communication Problem 34 34
Sensing Intermittently 23 23
Break 22 22
Insufficient Information 20 20
Battery Problem 20 20
Use of Device Problem 17 17
Computer Software Problem 10 10
Migration 7 7
Defective Device 6 6
Communication or Transmission Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Compatibility Problem 4 4
Pacemaker Found in Back-Up Mode 2 2
Product Quality Problem 2 2
Computer Operating System Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 1 2
Failure to Capture 1 1
Material Separation 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Protrusion/Extrusion 1 1
Thermal Decomposition of Device 1 1
Failure to Advance 1 1
Excessive Heating 1 1
Operating System Version or Upgrade Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Melted 1 1
Inaccurate Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Transmit Record 1 1
Application Program Problem 1 2
Failure to Disconnect 1 1
Low Sensing Threshold 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4203 4206
Insufficient Information 172 173
Discomfort 88 88
Pocket Erosion 79 79
Unspecified Infection 76 76
Wound Dehiscence 42 42
No Consequences Or Impact To Patient 23 23
Erosion 18 18
Arrhythmia 6 6
Hemorrhage/Bleeding 5 5
Hypersensitivity/Allergic reaction 4 4
Hematoma 3 3
Fever 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Syncope/Fainting 2 2
Anxiety 1 2
Complaint, Ill-Defined 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Vascular Dissection 1 1
Shock from Patient Lead(s) 1 1
No Information 1 1
Bone Fracture(s) 1 1
Scar Tissue 1 1
Tachycardia 1 1
Dizziness 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Atrial Fibrillation 1 1
Stroke/CVA 1 1
Fatigue 1 1

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