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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
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
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 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Pacing Problem 179 179
Break 68 68
No Pacing 43 43
Adverse Event Without Identified Device or Use Problem 42 42
Inflation Problem 42 42
Material Separation 18 18
Fracture 12 12
Failure to Sense 10 10
Insufficient Information 10 10
Material Integrity Problem 10 10
Detachment of Device or Device Component 9 9
Appropriate Term/Code Not Available 9 9
Material Rupture 9 9
Failure to Capture 8 8
Leak/Splash 8 8
Material Too Rigid or Stiff 7 7
Failure to Infuse 6 6
Material Fragmentation 6 6
Deflation Problem 5 5
Fluid Leak 5 5
Loss of Threshold 5 5
Material Twisted/Bent 5 5
Use of Device Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Defective Device 4 4
Deformation Due to Compressive Stress 4 4
Nonstandard Device 4 4
Detachment Of Device Component 4 4
Burst Container or Vessel 4 4
Accessory Incompatible 4 4
Disconnection 3 3
Electrical /Electronic Property Problem 3 3
Connection Problem 3 3
Malposition of Device 3 3
Defective Component 3 3
Over-Sensing 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Device Dislodged or Dislocated 3 3
Device Operates Differently Than Expected 3 3
Device Sensing Problem 3 3
Gas Leak 3 3
Human-Device Interface Problem 3 3
Patient Device Interaction Problem 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Difficult or Delayed Separation 2 2
High Capture Threshold 2 2
Impedance Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Biocompatibility 2 2
Material Deformation 2 2
Retraction Problem 2 2
Off-Label Use 2 2
Material Puncture/Hole 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Failure to Advance 2 2
Capturing Problem 2 2
Entrapment of Device 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
Pacing Intermittently 2 2
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
Pacing Inadequately 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
Activation, Positioning or SeparationProblem 1 1
Patient-Device Incompatibility 1 1
Ambient Noise Problem 1 1
Application Program Version or Upgrade Problem 1 1
Expiration Date Error 1 1
Physical Resistance 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Insufficient Flow or Under Infusion 1 1
Unraveled Material 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Moisture or Humidity Problem 1 1
Material Protrusion/Extrusion 1 1
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 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 98 98
Cardiac Tamponade 31 32
Cardiac Perforation 27 27
No Information 20 20
No Patient Involvement 17 17
Death 16 16
Cardiac Arrest 15 16
Pericardial Effusion 11 11
Arrhythmia 10 11
No Code Available 9 9
Low Blood Pressure/ Hypotension 8 8
Perforation 6 6
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 5 5
Hemorrhage/Bleeding 5 5
Atrial Fibrillation 4 4
Cardiopulmonary Arrest 4 4
Unspecified Infection 4 4
Internal Organ Perforation 4 4
Not Applicable 4 4
Blood Loss 4 4
Insufficient Information 4 4
Tachycardia 3 3
Thrombosis 2 2
Pain 2 2
Myocardial Infarction 2 2
Increased Sensitivity 2 2
Ventricular Tachycardia 2 2
Perforation of Vessels 2 2
Erosion 2 2
Bradycardia 2 2
Aortic Valve Stenosis 2 2
High Blood Pressure/ Hypertension 2 2
Complete Heart Block 2 2
Loss of consciousness 2 2
Needle Stick/Puncture 2 2
Palpitations 1 1
Increased Respiratory Rate 1 1
Diaphoresis 1 1
Loss Of Pulse 1 1
Patient Problem/Medical Problem 1 1
Tissue Breakdown 1 1
Asystole 1 1
Syncope 1 1
Atrial Flutter 1 1
Chest Pain 1 1
Hemothorax 1 1
Failure of Implant 1 1
Dementia 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Embolism 1 1
Weakness 1 1
Dizziness 1 1
Swelling 1 1
Heart Failure 1 1
Rupture 1 1
Torsades-de-Pointes 1 1
Urinary Retention 1 1
Ventricular Fibrillation 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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