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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Definition These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
Product CodeNKE
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
33 48 29 29 30 19

MDR Year MDR Reports MDR Events
2016 515 515
2017 607 607
2018 1005 1005
2019 795 795
2020 806 806
2021 838 838

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1405 1405
Over-Sensing 509 509
High impedance 413 413
Premature Discharge of Battery 331 331
Pacing Problem 315 315
Unable to Obtain Readings 210 210
Inappropriate or Unexpected Reset 209 209
Pacemaker Found in Back-Up Mode 177 177
Incorrect, Inadequate or Imprecise Resultor Readings 174 174
Device Operates Differently Than Expected 159 159
Ambient Noise Problem 149 149
Failure to Capture 147 147
Reset Problem 136 136
Signal Artifact/Noise 126 126
Low impedance 100 100
Device Sensing Problem 96 96
Mechanical Problem 93 93
Device Displays Incorrect Message 78 78
Appropriate Term/Code Not Available 77 77
Failure to Interrogate 76 76
Incorrect Measurement 62 62
Impedance Problem 61 61
Defective Device 58 58
Use of Device Problem 57 57
Capturing Problem 54 54
Data Problem 54 54
Connection Problem 51 51
Battery Problem 48 48
Telemetry Discrepancy 42 42
Under-Sensing 40 40
Pocket Stimulation 39 39
Communication or Transmission Problem 37 37
High Capture Threshold 37 37
Off-Label Use 36 36
Misconnection 36 36
Operating System Version or Upgrade Problem 33 33
Premature Elective Replacement Indicator 27 27
Migration or Expulsion of Device 23 23
Nonstandard Device 21 21
Difficult to Interrogate 21 21
False Alarm 20 20
No Pacing 20 20
Loose or Intermittent Connection 18 18
No Device Output 16 16
Output Problem 16 16
Interrogation Problem 16 16
Electromagnetic Interference 15 15
Difficult to Insert 12 12
Electrical /Electronic Property Problem 12 12
Fitting Problem 12 12
Intermittent Capture 10 10
Insufficient Information 10 10
Protective Measures Problem 10 10
Wireless Communication Problem 9 9
Missing Test Results 8 8
False Positive Result 8 8
Pacing Intermittently 8 8
Difficult to Remove 8 8
Migration 8 8
Material Integrity Problem 7 7
Patient-Device Incompatibility 7 7
Premature End-of-Life Indicator 6 6
Failure to Read Input Signal 5 5
Failure to Disconnect 4 4
Failure to Sense 4 4
Pacing Inadequately 4 4
Programming Issue 4 4
Human-Device Interface Problem 4 4
Device Dislodged or Dislocated 4 4
Battery Problem: High Impedance 3 3
Problem with Software Installation 3 3
Break 3 3
Application Program Problem 3 3
Application Program Version or Upgrade Problem 3 3
Out-Of-Box Failure 3 3
Unexpected Therapeutic Results 3 3
Contamination of Device Ingredient or Reagent 3 3
Loss of Data 3 3
Power Problem 3 3
Device Difficult to Program or Calibrate 3 3
Failure to Convert Rhythm 3 3
Pacing Asynchronously 3 3
Device Alarm System 2 2
Misassembled 2 2
Improper Device Output 2 2
Device Contamination With Biological Material 2 2
Device Contamination with Body Fluid 2 2
Improper or Incorrect Procedure or Method 2 2
Incorrect Interpretation of Signal 2 2
Display or Visual Feedback Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Noise, Audible 2 2
Unintended Electrical Shock 2 2
Intermittent Energy Output 1 1
Material Too Soft/Flexible 1 1
No Apparent Adverse Event 1 1
Temperature Problem 1 1
Patient Data Problem 1 1
Battery Problem: Low Impedance 1 1
Use of Incorrect Control Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1725 1725
Unspecified Infection 1061 1061
No Clinical Signs, Symptoms or Conditions 468 468
No Consequences Or Impact To Patient 308 308
No Code Available 208 208
Sepsis 184 184
Death 125 125
Pocket Erosion 124 124
Syncope 115 115
Insufficient Information 95 95
Hematoma 92 92
Dizziness 66 66
No Patient Involvement 61 61
Muscle Stimulation 60 60
Erosion 58 58
Complaint, Ill-Defined 50 50
Bradycardia 44 44
Discomfort 43 43
Pain 40 40
Dyspnea 38 38
Fatigue 33 33
Endocarditis 28 28
Device Overstimulation of Tissue 28 28
Syncope/Fainting 27 27
Swelling 23 23
Fall 22 22
Cardiac Arrest 22 22
Arrhythmia 20 20
Undesired Nerve Stimulation 20 20
Wound Dehiscence 20 20
Atrial Fibrillation 18 18
Chest Pain 17 17
No Information 16 16
Palpitations 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Fever 12 12
Erythema 11 11
Purulent Discharge 11 11
Twiddlers Syndrome 11 11
Weakness 10 10
Pneumothorax 10 10
Bacterial Infection 9 9
Staphylococcus Aureus 9 9
Low Blood Pressure/ Hypotension 9 9
Ventricular Tachycardia 8 8
Head Injury 8 8
Heart Failure 7 7
Ventricular Fibrillation 7 7
Pericardial Effusion 7 7
Septic Shock 7 7
Non specific EKG/ECG Changes 7 7
Inflammation 6 6
Thrombus 6 6
Tachycardia 6 6
Pleural Effusion 6 6
Nausea 6 6
Necrosis 5 5
Bruise/Contusion 5 5
Cellulitis 5 5
Patient Problem/Medical Problem 5 5
Presyncope 5 5
Chills 5 5
Complete Heart Block 5 5
Loss of consciousness 4 4
Failure of Implant 4 4
Congestive Heart Failure 4 4
Fainting 4 4
Burning Sensation 4 4
Itching Sensation 4 4
Swelling/ Edema 4 4
Asystole 4 4
Myocardial Infarction 3 3
Headache 3 3
Edema 3 3
Respiratory Distress 3 3
Injury 3 3
Loss Of Pulse 3 3
Blood Loss 3 3
Cardiogenic Shock 3 3
Impaired Healing 3 3
Abscess 3 3
Atrial Flutter 3 3
Atrial Tachycardia 3 3
Hiccups 3 3
Hypersensitivity/Allergic reaction 3 3
Irritation 3 3
Thrombosis 3 3
Torsades-de-Pointes 2 2
Cardiac Tamponade 2 2
Malaise 2 2
Vascular Dissection 2 2
Shock from Patient Lead(s) 2 2
Heart Failure/Congestive Heart Failure 2 2
Fluid Discharge 2 2
Unspecified Heart Problem 2 2
Insufficiency, Valvular 2 2
Skin Erosion 2 2
Rash 2 2
Renal Failure 2 2
Cardiomyopathy 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jul-13-2021
2 Boston Scientific Corporation II Jul-02-2021
3 Boston Scientific Corporation II Jan-15-2018
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Apr-30-2021
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-10-2018
6 St Jude Medical Inc. II Jun-12-2018
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