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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)
2017 2018 2019 2020 2021 2022
48 29 29 30 26 18

MDR Year MDR Reports MDR Events
2017 607 607
2018 1005 1005
2019 795 795
2020 806 806
2021 1177 1177
2022 1082 1082

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1612 1612
Premature Discharge of Battery 627 627
Over-Sensing 570 570
High impedance 464 464
Incorrect, Inadequate or Imprecise Result or Readings 452 452
Pacing Problem 438 438
Inappropriate or Unexpected Reset 243 243
Unable to Obtain Readings 220 220
Signal Artifact/Noise 195 195
Failure to Capture 172 172
Pacemaker Found in Back-Up Mode 160 160
Low impedance 141 141
Reset Problem 138 138
Defective Device 120 120
Ambient Noise Problem 115 115
Appropriate Term/Code Not Available 110 110
Battery Problem 105 105
Device Sensing Problem 103 103
Mechanical Problem 103 103
Device Operates Differently Than Expected 87 87
Failure to Interrogate 84 84
Impedance Problem 71 71
Device Displays Incorrect Message 70 70
Data Problem 66 66
Incorrect Measurement 65 65
High Capture Threshold 61 61
Connection Problem 54 54
Use of Device Problem 49 49
Capturing Problem 48 48
Pocket Stimulation 44 44
Under-Sensing 43 43
Misconnection 42 42
False Alarm 41 41
Off-Label Use 41 41
Telemetry Discrepancy 40 40
Interrogation Problem 40 40
Operating System Version or Upgrade Problem 33 33
Communication or Transmission Problem 33 33
Premature Elective Replacement Indicator 27 27
Loose or Intermittent Connection 26 26
Migration or Expulsion of Device 26 26
No Pacing 25 25
Electromagnetic Interference 22 22
Nonstandard Device 20 20
Difficult to Interrogate 17 17
Output Problem 15 15
Failure to Read Input Signal 14 14
Insufficient Information 13 13
Migration 12 12
Electrical /Electronic Property Problem 12 12
False Positive Result 11 11
Intermittent Capture 11 11
Difficult to Insert 11 11
Wireless Communication Problem 11 11
Protective Measures Problem 10 10
Fitting Problem 10 10
Material Integrity Problem 9 9
Missing Test Results 8 8
Pacing Intermittently 8 8
Unexpected Therapeutic Results 7 7
Patient-Device Incompatibility 7 7
Failure to Disconnect 6 6
Difficult to Remove 6 6
Pacing Inadequately 6 6
Premature End-of-Life Indicator 6 6
Display or Visual Feedback Problem 6 6
No Device Output 5 5
Pacing Asynchronously 5 5
Failure to Sense 5 5
Device Dislodged or Dislocated 5 5
Human-Device Interface Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Break 4 4
Device Alarm System 3 3
Inaccurate Synchronization 3 3
Failure to Convert Rhythm 3 3
Device Difficult to Program or Calibrate 3 3
Battery Problem: High Impedance 3 3
Power Problem 3 3
Problem with Software Installation 3 3
Application Program Problem 3 3
Application Program Version or Upgrade Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Loss of Data 3 3
Device Contamination With Biological Material 2 2
Out-Of-Box Failure 2 2
Device Contamination with Body Fluid 2 2
Programming Issue 2 2
No Apparent Adverse Event 2 2
Noise, Audible 2 2
Unintended Electrical Shock 2 2
Product Quality Problem 2 2
Incorrect Interpretation of Signal 2 2
Improper or Incorrect Procedure or Method 2 2
Misassembled 2 2
Device Emits Odor 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
Circuit Failure 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1463 1463
No Clinical Signs, Symptoms or Conditions 1351 1351
Unspecified Infection 1241 1241
No Consequences Or Impact To Patient 277 277
Sepsis 221 221
No Code Available 208 208
Pocket Erosion 153 153
Insufficient Information 125 125
Death 114 114
Hematoma 95 95
Syncope 91 91
Dizziness 85 85
Syncope/Fainting 82 82
Bradycardia 74 74
Device Overstimulation of Tissue 69 69
Discomfort 66 66
Erosion 60 60
No Patient Involvement 54 54
Muscle Stimulation 49 49
Dyspnea 47 47
Pain 46 46
Asystole 39 39
Fatigue 38 38
Complaint, Ill-Defined 38 38
Endocarditis 35 35
Fall 32 32
Arrhythmia 30 30
Chest Pain 25 25
Wound Dehiscence 24 24
Bacterial Infection 24 24
Cardiac Arrest 24 24
Undesired Nerve Stimulation 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Swelling 20 20
Atrial Fibrillation 18 18
Erythema 18 18
Fever 16 16
Palpitations 14 14
No Information 13 13
Tachycardia 13 13
Presyncope 12 12
Twiddlers Syndrome 11 11
Purulent Discharge 11 11
Non specific EKG/ECG Changes 10 10
Pneumothorax 10 10
Head Injury 10 10
Swelling/ Edema 10 10
Weakness 9 9
Pericardial Effusion 9 9
Inflammation 8 8
Low Blood Pressure/ Hypotension 7 7
Nausea 7 7
Pleural Effusion 7 7
Ventricular Fibrillation 7 7
Staphylococcus Aureus 7 7
Septic Shock 7 7
Ventricular Tachycardia 6 6
Thrombus 6 6
Chills 6 6
Loss of consciousness 6 6
Malaise 6 6
Cellulitis 6 6
Unspecified Heart Problem 6 6
Heart Failure/Congestive Heart Failure 5 5
Bruise/Contusion 5 5
Failure of Implant 5 5
Burning Sensation 5 5
Heart Failure 4 4
Impaired Healing 4 4
Anxiety 4 4
Fluid Discharge 4 4
Complete Heart Block 4 4
Hypoxia 4 4
Itching Sensation 4 4
Headache 4 4
Hemorrhage/Bleeding 4 4
Pneumonia 4 4
Necrosis 4 4
Myocardial Infarction 4 4
Congestive Heart Failure 4 4
Heart Block 4 4
Skin Inflammation/ Irritation 3 3
Fainting 3 3
Atrial Tachycardia 3 3
Abscess 3 3
Respiratory Distress 3 3
Pulmonary Edema 3 3
Hiccups 3 3
Irritation 3 3
Loss Of Pulse 3 3
Injury 3 3
Vomiting 3 3
Skin Erosion 3 3
Thrombosis 3 3
Cardiogenic Shock 2 2
Brain Injury 2 2
Seizures 2 2
Twitching 2 2
Patient Problem/Medical Problem 2 2
Vascular Dissection 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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