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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, pacemaker, temporary
Product CodeLDF
Regulation Number 870.3680
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 79 79
2018 91 91
2019 129 129
2020 83 83
2021 125 125
2022 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Pacing Problem 202 202
Break 87 87
Adverse Event Without Identified Device or Use Problem 58 58
No Pacing 47 47
Inflation Problem 44 44
Material Separation 25 25
Fracture 14 14
Failure to Sense 12 12
Material Rupture 11 11
Material Integrity Problem 11 11
Insufficient Information 10 10
Detachment of Device or Device Component 10 10
Failure to Capture 9 9
Appropriate Term/Code Not Available 9 9
Leak/Splash 8 8
Material Too Rigid or Stiff 7 7
Failure to Infuse 6 6
Material Fragmentation 6 6
Material Twisted/Bent 6 6
Device Dislodged or Dislocated 6 6
Deflation Problem 5 5
Disconnection 5 5
Burst Container or Vessel 5 5
Fluid/Blood Leak 5 5
Tear, Rip or Hole in Device Packaging 5 5
Loss of Threshold 5 5
Use of Device Problem 5 5
Defective Device 4 4
Device Sensing Problem 4 4
Deformation Due to Compressive Stress 4 4
Nonstandard Device 4 4
Accessory Incompatible 4 4
Detachment Of Device Component 4 4
Material Deformation 4 4
Gas/Air Leak 4 4
Human-Device Interface Problem 3 3
Impedance Problem 3 3
High Capture Threshold 3 3
Patient Device Interaction Problem 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 3 3
Electrical /Electronic Property Problem 3 3
Entrapment of Device 3 3
Capturing Problem 3 3
Connection Problem 3 3
Device Operates Differently Than Expected 3 3
Malposition of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 3 3
Over-Sensing 3 3
Difficult to Remove 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Retraction Problem 2 2
Component Missing 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Failure to Advance 2 2
Material Frayed 2 2
Difficult to Insert 2 2
Intermittent Capture 2 2
No Device Output 2 2
Migration or Expulsion of Device 2 2
Incorrect Measurement 2 2
Off-Label Use 2 2
Material Puncture/Hole 2 2
Product Quality Problem 2 2
Pacing Inadequately 2 2
Pacing Intermittently 2 2
Separation Problem 2 2
Difficult or Delayed Separation 2 2
Biocompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Moisture or Humidity Problem 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Missing Information 1 1
Migration 1 1
Material Too Soft/Flexible 1 1
Particulates 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Pacemaker Found in Back-Up Mode 1 1
Pacing Asynchronously 1 1
Mechanical Problem 1 1
Loose or Intermittent Connection 1 1
Signal Artifact/Noise 1 1
Backflow 1 1
Electromagnetic Interference 1 1
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1
Device Expiration Issue 1 1
Expiration Date Error 1 1
Physical Resistance 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 207 207
No Known Impact Or Consequence To Patient 159 159
No Clinical Signs, Symptoms or Conditions 150 150
Cardiac Tamponade 39 40
Cardiac Perforation 32 32
Cardiac Arrest 22 23
No Information 20 20
No Patient Involvement 17 17
Death 16 16
Arrhythmia 14 15
Pericardial Effusion 12 12
Insufficient Information 11 11
Hemorrhage/Bleeding 11 11
No Code Available 9 9
Low Blood Pressure/ Hypotension 8 8
Perforation 8 8
Bradycardia 7 7
Foreign Body In Patient 7 7
Unspecified Infection 6 6
Atrial Fibrillation 5 5
Device Embedded In Tissue or Plaque 5 5
Not Applicable 4 4
Blood Loss 4 4
Cardiopulmonary Arrest 4 4
Internal Organ Perforation 4 4
Tachycardia 3 3
Erosion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Heart Block 3 3
Complete Heart Block 2 2
Needle Stick/Puncture 2 2
Loss of consciousness 2 2
Ventricular Fibrillation 2 2
Ventricular Tachycardia 2 2
Perforation of Vessels 2 2
Aortic Valve Stenosis 2 2
Chest Pain 2 2
Thrombosis 2 2
Increased Sensitivity 2 2
Pain 2 2
High Blood Pressure/ Hypertension 2 2
Myocardial Infarction 2 2
Device Overstimulation of Tissue 1 1
Inflammation 1 1
Failure of Implant 1 1
Incontinence 1 1
Paralysis 1 1
Swelling 1 1
Torsades-de-Pointes 1 1
Urinary Retention 1 1
Hemothorax 1 1
Dementia 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Embolism 1 1
Micturition Urgency 1 1
Stroke/CVA 1 1
Atrial Flutter 1 1
Syncope 1 1
Air Embolism 1 1
Weakness 1 1
Dizziness 1 1
Diaphoresis 1 1
Heart Failure 1 1
Rupture 1 1
Palpitations 1 1
Increased Respiratory Rate 1 1
Loss Of Pulse 1 1
Tissue Breakdown 1 1
Pericarditis 1 1
Unspecified Tissue Injury 1 1
Patient Problem/Medical Problem 1 1
Thrombosis/Thrombus 1 1
Asystole 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Jul-29-2019
2 Oscor, Inc. I Nov-08-2018
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