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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
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 129 129
2020 83 83
2021 125 125
2022 117 117
2023 206 206
2024 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Pacing Problem 200 200
Break 88 88
Adverse Event Without Identified Device or Use Problem 65 65
No Pacing 53 53
Material Separation 43 43
Inflation Problem 35 35
Material Integrity Problem 23 23
Detachment of Device or Device Component 20 20
Deformation Due to Compressive Stress 19 19
Fracture 16 16
Burst Container or Vessel 15 15
Insufficient Information 15 15
Failure to Capture 11 11
Failure to Sense 11 11
Material Too Rigid or Stiff 11 11
Material Rupture 10 10
Failure to Infuse 9 9
Connection Problem 9 9
Gas/Air Leak 9 9
Material Twisted/Bent 8 8
Material Fragmentation 8 8
Fluid/Blood Leak 7 7
Leak/Splash 7 7
Device Dislodged or Dislocated 7 7
Material Split, Cut or Torn 7 7
Material Frayed 6 6
Disconnection 6 6
Accessory Incompatible 5 5
Material Puncture/Hole 5 5
Device Sensing Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Loss of Threshold 5 5
Use of Device Problem 4 4
Defective Device 4 4
Difficult to Remove 4 4
Nonstandard Device 4 4
Deflation Problem 4 4
Patient Device Interaction Problem 4 4
Material Deformation 4 4
Physical Resistance/Sticking 3 3
Impedance Problem 3 3
Appropriate Term/Code Not Available 3 3
Pacing Inadequately 3 3
Device Damaged Prior to Use 3 3
Fitting Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 2 2
Retraction Problem 2 2
Malposition of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Advance 2 2
Biocompatibility 2 2
Over-Sensing 2 2
Product Quality Problem 2 2
Decrease in Pressure 2 2
Off-Label Use 2 2
Intermittent Capture 2 2
Electrical /Electronic Property Problem 2 2
Difficult to Insert 2 2
High Capture Threshold 2 2
Therapeutic or Diagnostic Output Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Naturally Worn 2 2
Material Protrusion/Extrusion 2 2
Difficult or Delayed Separation 2 2
Missing Information 2 2
Failure to Deflate 1 1
Migration 1 1
Material Too Soft/Flexible 1 1
Human-Device Interface Problem 1 1
No Apparent Adverse Event 1 1
Output Problem 1 1
Positioning Problem 1 1
Noise, Audible 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Signal Artifact/Noise 1 1
Backflow 1 1
Positioning Failure 1 1
Electromagnetic Interference 1 1
Pacemaker Found in Back-Up Mode 1 1
Unable to Obtain Readings 1 1
Pacing Intermittently 1 1
Particulates 1 1
Perivalvular Leak 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
No Device Output 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Activation, Positioning or Separation Problem 1 1
Device Operates Differently Than Expected 1 1
Capturing Problem 1 1
Communication or Transmission Problem 1 1
Patient-Device Incompatibility 1 1
Application Program Version or Upgrade Problem 1 1
Insufficient Flow or Under Infusion 1 1
Low impedance 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 358 358
No Consequences Or Impact To Patient 128 128
No Known Impact Or Consequence To Patient 112 112
Cardiac Perforation 43 43
Cardiac Tamponade 33 34
Exposure to Body Fluids 28 28
Insufficient Information 27 27
Cardiac Arrest 22 23
Arrhythmia 17 18
Pericardial Effusion 16 16
Death 10 10
Hemorrhage/Bleeding 10 10
Perforation 9 9
Low Blood Pressure/ Hypotension 8 8
No Patient Involvement 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Bradycardia 7 7
Ventricular Fibrillation 6 6
No Information 6 6
No Code Available 5 5
Foreign Body In Patient 5 5
Device Embedded In Tissue or Plaque 5 5
Tachycardia 5 5
Asystole 4 4
Heart Block 4 4
Unspecified Infection 4 4
Failure of Implant 4 4
Atrial Fibrillation 3 3
Cardiopulmonary Arrest 3 3
Internal Organ Perforation 3 3
Loss of consciousness 3 3
Needle Stick/Puncture 2 2
Aortic Valve Insufficiency/ Regurgitation 2 2
Myocardial Infarction 2 2
Perforation of Vessels 2 2
Dizziness 2 2
Pneumothorax 2 2
Increased Sensitivity 2 2
Stroke/CVA 2 2
Chest Pain 2 2
Bacterial Infection 2 2
Pulmonary Embolism 1 1
Syncope 1 1
Air Embolism 1 1
Incontinence 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Embolism 1 1
Fistula 1 1
Micturition Urgency 1 1
Sepsis 1 1
Rupture 1 1
Device Overstimulation of Tissue 1 1
Paralysis 1 1
Inflammation 1 1
Laceration(s) 1 1
Erosion 1 1
Unspecified Tissue Injury 1 1
Thrombosis/Thrombus 1 1
Unspecified Vascular Problem 1 1
Pericarditis 1 1
Valvular Insufficiency/ Regurgitation 1 1
Diaphoresis 1 1
Loss Of Pulse 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Tissue Breakdown 1 1
Vascular Dissection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Jul-29-2019
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